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X-Temp Master Formulation XTEMP

The document contains master formulation sheets for various medications, detailing their concentrations and preparation procedures. Each formulation includes sections for raw materials quality control, preparation steps, storage instructions, and references. The document emphasizes the importance of professional judgment in using the specified vehicle (X-Temp) for compounding these medications.

Uploaded by

tanguatmin91
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
482 views102 pages

X-Temp Master Formulation XTEMP

The document contains master formulation sheets for various medications, detailing their concentrations and preparation procedures. Each formulation includes sections for raw materials quality control, preparation steps, storage instructions, and references. The document emphasizes the importance of professional judgment in using the specified vehicle (X-Temp) for compounding these medications.

Uploaded by

tanguatmin91
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 102

Updated 12th June 2021

MASTER FORMULATION SHEETS

By:

Updated 12th June 2021


CONTENTS

Acetazolamide 25mg/ml ……………………………… 1

Allopurinol 20mg/ml ……………………………… 2

Alprazolam 1mg/ml ……………………………… 3

Aminophylline 3mg/ml ……………………………… 4

Amiodarone 5mg/ml ……………………………… 5

Amiodarone 40mg/ml ……………………………… 6

Amlodipine 1mg/ml ……………………………… 7

Atenolol 2mg/ml ……………………………… 8

Azathioprine 50mg/ml ……………………………… 9

Baclofen 10mg/ml ……………………………… 10

Bethanechol 5mg/ml ……………………………… 11

Bosentan 6.25mg/ml ……………………………… 12

Captopril 1.25mg/ml ……………………………… 13

Carbidopa/Levodopa (Sinemet) 1.25mg/5mg/ml ……………………………… 14

Carvedilol 1.67mg/ml ……………………………… 15

Chloral Hydrate 40mg/ml ……………………………… 16

Chloroquine Phosphate 15mg/ml ……………………………… 17

Clobazam 1mg/ml ……………………………… 18

Clonazepam 0.1mg/ml ……………………………… 19

Clonidine 0.01mg/ml ……………………………… 20

Clonidine 0.1mg/ml ……………………………… 21

Clopidogrel 5mg/ml ……………………………… 22

Clozapine 20mg/ml ……………………………… 23

Dapsone 2mg/ml ……………………………… 24

Dexamethasone 0.5mg/ml ……………………………… 25

Dexamethasone 1mg/ml ……………………………… 26

Diazoxide 10mg/ml ……………………………… 27

Diltiazem 12mg/ml ……………………………… 28


CONTENTS

Dipyridamole 10mg/ml ……………………………… 29

Dolasetron Mesylate 10mg/ml ……………………………… 30

Domperidone 1mg/ml ……………………………… 31

Domperidone 5mg/ml ……………………………… 32

Domperidone 10mg/ml ……………………………… 33

Enalapril 1mg/ml ……………………………… 34

Ethambutol 100mg/ml ……………………………… 35

Flecainide Acetate 20mg/ml ……………………………… 36

Flucytosine 10mg/ml ……………………………… 37

Flucytosine 50mg/ml ……………………………… 38

Folic Acid 1mg/ml ……………………………… 39

Gabapentin 100mg/ml ……………………………… 40

Granisetron 0.05mg/ml ……………………………… 41

Hydrochlorothiazide 5mg/ml ……………………………… 42

Hydrocortisone 1mg/ml ……………………………… 43

Hydrocortisone 2mg/ml ……………………………… 44

Hydroxychloroquine Sulfate 25mg/ml ……………………………… 45

Isoniazid 10mg/ml ……………………………… 46

Isoniazid 40mg/ml ……………………………… 47

Itraconazole 20mg/ml ……………………………… 48

Ketoconazole 20mg/ml ……………………………… 49

Labetalol 10mg/ml ……………………………… 50

Lamotrigine 1mg/ml ……………………………… 51

Levetiracetam 50mg/ml ……………………………… 52

Lisinopril 1mg/ml ……………………………… 53

Lorazepam 200mcg/ml ……………………………… 54

Melatonin 2mg/ml ……………………………… 55

Metolazone 1mg/ml ……………………………… 56


CONTENTS

Metoprolol 10mg/ml ……………………………… 57

Metronidazole (powder) 50mg/ml ……………………………… 58

Metronidazole (tablet) 10mg/ml ……………………………… 59

Morphine 10mg/5ml ……………………………… 60

Mycophenolate Mofetil 50mg/ml ……………………………… 61

Mycophenolate Mofetil 100mg/ml ……………………………… 62

Naproxen 25mg/ml ……………………………… 63

Naratriptan 0.5mg/ml ……………………………… 64

Nifedipine 4mg/ml ……………………………… 65

Nitrofurantoin 10mg/ml ……………………………… 66

Ondansetron 0.8mg/ml ……………………………… 67

Oseltamivir 15mg/ml ……………………………… 68

Phenobarbitone 10mg/ml ……………………………… 69

Prednisolone 5mg/ml ……………………………… 70

Procainamide 50mg/ml ……………………………… 71

Propranolol 2mg/ml ……………………………… 72

Propranolol 5mg/ml ……………………………… 73

Propylthiouracil 5mg/ml ……………………………… 74

Pyrazinamide 100mg/ml ……………………………… 75

Quinidine Sulfate 10mg/ml ……………………………… 76

Rifabutin 20mg/ml ……………………………… 77

Rimfapicin 25mg/ml ……………………………… 78

Sildenafil 2.5mg/ml ……………………………… 79

Sodium Phenylbutyrate 200mg/ml ……………………………… 80

Sotalol 5mg/ml ……………………………… 81

Spironolactone 1.25mg/ml ……………………………… 82

Spironolactone 5mg/ml ……………………………… 83

Sulfasalazine 100mg/ml ……………………………… 84


CONTENTS

Tacrolimus 0.5mg/ml ……………………………… 85

Terbinafine 25mg/ml ……………………………… 86

Theophylline 5mg/ml ……………………………… 87

Thiamine 20mg/ml ……………………………… 88

Tramadol 5mg/ml ……………………………… 89

Trimethoprim 10mg/ml ……………………………… 90

Ursodeoxycholic 25mg/ml ……………………………… 91

Ursodeoxycholic 50mg/ml ……………………………… 92

Valganciclovir 60mg/ml ……………………………… 93

Verapamil 50mg/ml ……………………………… 94

Warfarin 0.2mg/ml ……………………………… 95


MA ST E R F O RM U LA SHE E T Acetazolamide
Last updated :______________________
25mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Acetazolamide 250mg 12 tablets

X-Temp Pharm-D qs 120 mL


* Remark:
Solubility of Acetazolamide in water is 0.7mg/ml; Optimum pH stability is 4.0—5.0

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber


plastic bottle
150ml

Storage Room temperature


25 ± 2 oC
Stored in the dark

Expiry 60 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
2. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 89 –95
3. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 2 – 4

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Allopurinol
Last updated :______________________
20mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Allopurinol 300 mg 8 tablets

X-Temp Pharm-D qs 120 mL

* Remark:
Allopurinol is slightly soluble in water.
Allopurinol is light-sensitive

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 150ml.
Shake bottle before used.
Storage Fridge temperature
2– 8oC
Keep away from light

Expiry 60 days

References: Supported by:


1. Am J Health Syst. Pharm, 53(16):1944-1949, 1996
2. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 96-102
3. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 9-11

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Alprazolam
Last updated :______________________
1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Alprazolam 0.5mg 120 tablets

X-Temp Pharm-D qs 60 mL
* Remark:
Alprazolam is white or off-white crystalline powder which is insoluble in water.
Alprazolam products should be stored in tight, light-resistant containers at controlled room temperatures of
20 to 25oC

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml

Storage Room temperature


20 to 25oC
Stored in the dark

Expiry 60 days

References:
Supported by:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006
2. Am J Health Syst Pharm 1998;55:1915-20
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 22

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Aminophylline
Last updated :______________________
3mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Aminophylline inj
12 ml
250mg/10ml

X-Temp Pharm-D qs 100 mL

* Remark:
Aminophylline has an aqueous solubility of 200mg/ml. Aminophylline exposed to air may gradually absorbed
carbon dioxide and free theophlline, becoming turbid or developing crystals. Refrigeration encourages crystal
formation in some injections. For 21mg/ml suspension was not stable when stored at fridge temperature,
formed crystal

2. Procedure (√)

1. Measure out X-temp

2. Draw up the required amount of injection using a filter needle or filter straw and transfer to a
measuring cylinder

3. Gradually add X-temp vehicle in small amounts to the injection and mix well until a liquid is
formed.

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the syrup into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC
Do not keep in the fridge
Keep away from light

Expiry 91 days

References:
1. Chong E et al. “Stability of aminophylline in extemporaneously prepared oral suspensions” J Supported by:
Informed Pharmacother. 2000;2:100-6
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 31
Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
Rev01/2013-Mar

MA ST E R F O RM U LA SHE E T Amiodarone
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/ Checked


Ingredients Batch no. EXP date Measured by
Manufacturer measurement by

Amiodarone 200mg Cordarone* 3 tablets

Sodium bicarbonate 5% Approx 10mL**

X-Temp Pharm-D qs 120 mL


* Remark:
Amiodarone HCl is a white to cream crystalline powder that has solubility in water of about
0.72mg/ml. Amiodarone has a pKa of about 6.6. It should be stored in tight containers at
controlled room temperature & protected from light.
** Approximately 10ml of Sodium bicarbonate 5% is needed to adjust 120ml X-Temp,
depending on the brand of Amiodarone used due to different excipients in the tablet.
2. Procedure (√)
1. Measure out X-temp. Adjust the pH of X-Temp to pH 6-7 using Sodium Bicarbonate 5% solution.
2. Soak the tablet with small amount of water to soften the tablet.
Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp (pH adjusted) to levigate the powder to form a smooth paste
3. Gradually add X-temp (pH adjusted) vehicle in small amounts to the paste, mix well until a
liquid is formed. Transfer the contents into the graduate. Use additional vehicle to rinse the
remaining drug from the mortar and add to the graduate
4. Make up the final volume in the graduated using more X-temp (pH adjusted) vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 120ml

Storage a) Room temperature


25 ± 2 oC
b) Fridge temperature

Expiry a) 42 days
b) 91 days

References: Supported by:

1. J of Ped Pharm Prac 1999;4(4):186-189


2. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 103-109
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 34

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
Rev01/2013-Mar

MA ST E R F O RM U LA SHE E T Amiodarone
Last updated :______________________
40mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/ Checked


Ingredients Batch no. EXP date Measured by
Manufacturer measurement by

Amiodarone 200mg Cordarone* 20 tablets

Sodium bicarbonate 5% Approx 10mL**

X-Temp Pharm-D qs 100 mL


* Remark:
Amiodarone HCl is a white to cream crystalline powder that has solubility in water of about
0.72mg/ml. Amiodarone has a pKa of about 6.6. It should be stored in tight containers at
controlled room temperature & protected from light.
** Approximately 10ml of Sodium bicarbonate 5% is needed to adjust 100ml X-Temp,
depending on the brand of Amiodarone used due to different excipients in the tablet.
2. Procedure (√)
1. Measure out X-temp. Adjust the pH of X-Temp to pH 6-7 using Sodium Bicarbonate 5% solution.
2. Soak the tablet with small amount of water to soften the tablet.
Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp (pH adjusted) to levigate the powder to form a smooth paste
3. Gradually add X-temp (pH adjusted) vehicle in small amounts to the paste, mix well until a
liquid is formed. Transfer the contents into the graduate. Use additional vehicle to rinse the
remaining drug from the mortar and add to the graduate
4. Make up the final volume in the graduated using more X-temp (pH adjusted) vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml

Storage Room temperature


25 ± 2 oC
Keep away from light
Shake the bottle before
use
Expiry 28 days

References: Supported by:

1. J of Ped Pharm Prac 1999;4(4):186-189


2. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 103-109
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 34

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Amlodipine
Last updated :______________________
1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Amlodipine 5mg
12 tablets
(besylate)

X-Temp Pharm-D qs 60 mL

* Remark:
Amlodipine besylate is slightly soluble in water. The commercial tablet should be packaged in tight, light-
resistance containers and stored at controlled room temperature.

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablet in the mortar. Add 3-4 ml of water to disintegrate the tablets
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml
Storage a. Fridge temperature
2 – 8 oC
b. Room temperature
25 ± 2 oC

Expiry a. 90 days
b. 60 days
References:
1. J American Pharm. Assoc. 1999; 39: 375-377 (Besylate)
Supported by:
2. Stability of Extemporaneously Compounded Amlodipine Besylate Oral Suspensions. CJHP
2016; 69(4)
3. Paddock Laboratories, Secundum Artem Vol 14, No 1.
4. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 35

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Atenolol
Last updated :______________________
2mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Atenolol 50mg 4 tablets

Glycerin 2 ml

X-Temp Pharm-D qs 100 mL

* Remark:
Atenolol has solubility of 26.5mg/ml at 37oC. Atenolol exhibits maximum stability at pH 4.0. Exposure of at-
enolol solutions to UV light resulted in drug decomposition at both physiologic & acid pH.

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add glycerin to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 50ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 90 days

References:
1. Patel D at el, Short-term stability of atenolol in oral liquid formulations. Int J Pharm Com- Supported by:
pound. 1997;1:437-9.
2. Paddock Laboratories Secundum Artem Vol 14 No 1
3. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 55

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Azathioprine
Last updated :______________________
50mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Azathioprine 50mg 50 tablets

X-Temp Pharm-D qs 50 mL
* Remark:
Azathioprine is slightly soluble in water, about 0.13mg/ml
CYTOTOXIC– Must use designated cytotoxic equipment and prepare in segregated area. Wear protective
equipment

2. Procedure (√)

1. Measure out X-temp


2. Wet the tablets with small of X-Temp before crushing the tablet to prevent exposure to medicine
powder. Crush the tablets to form a smooth paste.

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal. Additional label: Cytotoxic

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber


plastic bottle 50ml

Storage Room temperature


25 ± 2 oC
Stored in the dark

Expiry 60 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006 Supported by:

2. Am J Health-Syst Pharm. 1996; 53: 1944-49


3. Paddock Laboratories, Secundum Artem Vol 5 No 4.
4. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 36-38

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Baclofen
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Baclofen 10 mg 120 tablets

X-Temp Pharm-D qs 120 mL

* Remark:
Solubility of Baclofen in water is 7.5mg/ml

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well

5. Transfer the suspension into bottle


6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber plastic


bottle 150ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 60 days

References:
1. Am J Health Syst Pharm 53 (18):2179-2184, 1996 Supported by:

2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared


from commercially available products. JPPS 9(3): 398-426,2006
3. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 39 – 40

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Bethanechol
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Bethanechol 10mg 50 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Bethanechol Chloride occurs as hygroscopic colorless powder. It has a characteristic fishy odor. Bethanechol
is reported to be very soluble in water, having an aqueous solubility of about 1.67g/ml.
Bethanechol chloride should protected from temperatures above 40oC. The injection should be protected from
freezing.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 60 days

References:
1. Allen LV, Erickson MA “Stability of bethanechol chloride, pyrazinamide, quinidine sulfate,
rifampin and tetracycline hydrochloride inextemporaneously compounded oral liquids.” Am J Supported by:
Health Syst Pharm. 1998;55:1804-9
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 71
Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Bosentan
Last updated :______________________
6.25mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Bosentan 62.5mg Tracleer 10 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Tracleer 62.5mg and Tracleer 125mg are film coated tablets.

2. Procedure (√)
1. Measure out X-temp.
2. Soak the tablet with small amount of water/glycerin to remove the film-coat.
Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste.
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate.
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well.
5. Transfer the suspension into bottle.
6. Label and affix shrink seal.

3. Sample label : Affix here Special Instruction


Packaging bottle HDPE amber plastic
bottle 100ml

Storage Room temperature


25 ± 2 oC
Store in the dark

Expiry 30 days

References:
Supported by:
1. Malik A., Gorman G., Coward L., and Arnold J.J. “Stability of an Extemporaneously
Compounded Oral suspension of Bosentan.” Hosp Pharm 2016; 51(5):389-395.
2. Tracleer PI.

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Captopril
Last updated :______________________
1.25mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control


Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement
Captopril 25mg Hexal AG 5 tablets
Drug Houses
of Australia
Ascobic Acid 100mg (Asia) Pte 5 tablets

X-Temp Pharm-D qs 100 mL


Remark:
Captopril soluble in water & ethanol ; decomposed or oxidized easily.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste
3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic


bottle 100ml

Storage Room temperature


25 ± 2 oC

Expiry 14 days

Supported by:

Reference:
Local Stability Study in Malaysia at Zone 4 climate. Conducted by Pharm-D Sdn Bhd (30/12/09—
27/02/10)

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments.
MA ST E R F O RM U LA SHE E T
Last updated :______________________
Carbidopa/ Levodopa (Sinemet®)
1.25mg carbidopa/5mg levodopa/ml
Updated by :_______________________
Oral Suspension
Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Sinemet ® 25/100 mg MSD 5 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Levodopa turns dark when exposed to air; Oxidation of levodopa in alkaline solution leads to formation of
inactive compound such as melanin

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber


plastic bottle 100ml

Storage Fridge temperature


2– 8oC
Keep away from light

Expiry 28 days

References: Supported by:

1. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 158-165


2. Paddock Laboratories, Secundum Artem Vol 14 No 3
3. Sick Kids Pharmacy Formulation Sheet (updated April 2007)

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Carvedilol
Last updated :______________________
1.67mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Carvedilol 25mg 8 tablets

Sterile Water 20 mL

X-Temp Pharm-D qs 120 mL

Remark:
Carvedilol is a white to of-white crystalline powder. It is practically insoluble in water.

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Levigate with sterile water for irrigation to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber plastic


bottle 120ml

Storage Room temperature


25 ± 2 oC
Stored in the dark

Expiry 84 days

Supported by:
Reference:
1. Rita K. Jew, Winson Soo-Hoo & Sarah C. Erush “Extemporaneous Formulations for Pediatric, Geriat-
ric & Special Needs Patient, 2nd Ed” pg 19
2. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 103

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O MU LA S HE E T Chloral Hydrate
Last updated :______________________
40mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Chloral Hydrate 4000mg or 4g

X-Temp Pharm-D qs 100 mL


* Remark:
Chloral hydrate occurs as transparent colorless or white crystals and has an aromatic penetrating, slightly
acrid odor and a caustic bitter taste.
Chloral hydrate is very soluble in water. A 10% chloral hydrate solution in water has a pH of 3.5 to 5.5

2. Procedure (√)

1. Measure out X-temp


2. Measure the require amount of powder.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

Special Instruction
3. Sample label : Affix here
Packaging bottle HDPE plastic
amber bottle 100ml

Storage Room temperature


30 ± 2 oC; 75% RH
Keep away from light.
Should not be freeze

Expiry 6 months

Supported by:

Reference:
Local Stability Study in Malaysia at Zone 4 climate. Conducted by Pharm-D Sdn Bhd (28/12/2015 —
05/07/2016)

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments.
MA ST E R F O RM U LA SHE E T Chloroquine Phosphate
Last updated :______________________
15mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Chloroquine
6 tablets
Phosphate 250mg

X-Temp Pharm-D qs 100 mL

* Remark:
Chloroquine Phosphate is freely soluble in water & has the aqueous solubility of 250mg/ml.
Chloroquine Phosphate is sensitive to light, discoloring upon exposure to light.

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber


plastic bottle
100ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 60 days

Reference: Supported by:

1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared


from commercially available products. JPPS 9(3): 398-426,2006
2. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 79-81

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Clobazam
Last updated :______________________
1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Clobazam 10mg 10 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Clobazam is white to almost white crystalline powder.
Clobazam is slightly soluble in water, with solubility 188mg/L. It is sparingly soluble in ethanol and freely
soluble in methylene chloride.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 120ml
Storage Room temperature
25 ± 2 oC

Expiry 24 weeks (168 days)

References:
1. Lwin EMP, Ellis D, Song Y, et al. Stability Studies of Extemporaneously Compounded Clobazam Oral
Suspension. Annals of Pharmacotherapy 2016, 50 (2):155-6.
Supported by:
2. IWK Health Centre Formulation Sheet
3. National Center for Biotechnology Information. PubChem Compound Database; CID=2789,
https://pubchem.ncbi.nlm.nih.gov/compound/2789 .

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
M A S TE R F O M U L A S H E E T Clonazepam
Last updated :______________________
0.1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Clonazepam 2mg* 5 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Clonazepam oral drops formulation is commercially available
Clonazepam practically insoluble in water, <0.1mg/ml in water at 25oC; degradation occurs principally via
hydrolysis.
Clonazepam solution exhibit loss due to sorption to PVC containers

2. Procedure (√)
1. Measure out X-temp
2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle Amber glass bottle 100ml


Avoid PVC containers
Shake well before use

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 60 days
References: Supported by:
1. Am J Health Syst Pharm, 53(16):1944-1949,1996
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006
3. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 138 - 143

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X‐Temp as the vehicle though X‐Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X‐Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Clonidine Hydrochloride
Last updated :______________________
0.01mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Clonidine HCl 100mcg 10 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Clonidine HCl is a white, odorless, crystalline powder with a bitter taste. It has an aqueous solubility of
77mg/ml.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 91 days

References:
Supported by:
1. Mary H H Ensom, Diane Décarie, Stability of Extemporaneously Compounded Clonidine in
Glass and Plastic Bottles and Plastic Syringes. CJHP 2014; 67 (4)
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 146

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Clonidine Hydrochloride
Last updated :______________________
0.1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Clonidine HCl 200mcg 50 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Clonidine HCl is a white, odorless, crystalline powder with a bitter taste. It has an aqueous solubility of
77mg/ml.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml

Storage Fridge temperature


2 - 8 oC
Keep away from light

Expiry 28 days
References:
1. Levinson M.L et al “Stability of an extemporaneously compounded clonidine hydrochloride oral
liquid” Am J Hosp Pharm, 49(1):122-125, 1992
Supported by:
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006
3. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 144
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 146

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Clopidogrel
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Clopidogrel 75mg 8 tablets

X-Temp Pharm-D qs 120 mL


* Remark:
Clopidogrel Bisulfate is a white to off-white powder. It is freely soluble in water.
The preparation was palatable, with a slightly gritty consistency & a slightly bitter after taste; the bitterness
intensified slightly between 28 and 60 days but remained fairly mild.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablet to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle Amber plastic bottle


120ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 60 days

References: Supported by:


1. Skillman KL, Caruthers RL, Johnson CE “Stability of an extemporaneously prepared Clopidogrel
Oral Suspension” Am J Health Syst Pharm 2010;67(7):559-561
2. Secundum Artem Vol 16 No 3

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
M A S TE R F O M U L A S H E E T Clozapine
Last updated :______________________
20mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Clozapine 100mg
Novartis 20 tablets
(Clozaril)

X-Temp Pharm-D qs 100 mL

* Remark:
Clozapine has poor solubility in water

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE plastic


bottle 100ml
Shake bottle before
used.
Storage Room temperature
25 ± 2 oC

Expiry 28 days

References: Supported by:

1. Can J Hosp Pharm 2005; 58: 279 - 84


2. Paddock Laboratories, Secundum Artem Vol 16 No 1
3. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 150-157

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X‐Temp as the vehicle though X‐Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X‐Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Dapsone
Last updated :______________________
2mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Dapsone 25mg 8 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Dapsone is a white to yellowish-white crystalline powder with bitter taste; very slightly soluble
in water. Dapsone may discolor if exposed tolight. No chemical change associated with the dis-
coloration has been detected.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml
Storage Fridge temperature
2– 8oC
Keep away from light

Expiry 91 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
2. Nahata et al, Stability of Dapsone in two oral liquid dosage form. Ann Pharmacother,
2000;34:848-50
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 172

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Dexamethasone
Last updated :______________________
0.5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control


Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement
Dexamethasone (Sod
Phosphate) injection Sabex Inc 12.5 mL
4mg/ml

X-Temp Pharm-D qs 100 mL

* Remark:
Dexamethasone is white crystalline powder.
1mg Dexamethasone (solubililty is 0.1mg/ml) = 1.1mg Dexamethasone acetate (insoluble in water); 1mg Dex-
amethasone = 1.3mg Dexamethasone Sod Phosphate (solubility 500mg/ml). Dexamethasone Sod phosphate is
very hygroscopic crystalline powder.

2. Procedure (√)

1. Measure out X-temp

2. Draw up the required amount of injection using a filter needle or filter straw and transfer to a
measuring cylinder

3. Gradually add X-temp vehicle in small amounts to the injection and mix well until a liquid is
formed.

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the syrup into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 91 days

References:
1. Wen-Lin Chow et al Stability of dexamethasone in extemporaneously prepared oral suspen- Supported by:
sions. Can J Hosp Pharm 2001;54:96-101
2. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 171—177
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 176—179

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Dexamethasone
Last updated :______________________
1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Dexamethasone 4mg Pharmascience 25 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Dexamethasone is white crystalline powder.
1mg Dexamethasone (solubililty is 0.1mg/ml) = 1.1mg Dexamethasone acetate (insoluble in water); 1mg
Dexamethasone = 1.3mg Dexamethasone Sod Phosphate (solubility 500mg/ml). Dexamethasone Sod phos-
phate is very hygroscopic crystalline powder.

2. Procedure (√)

1. Measure out X-temp

2. Grind the tablets to fine powder in the mortar.


Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate.
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the syrup into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction


Packaging bottle HDPE amber plastic
bottle 100ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 91 days

References:
1. Mary H H Ensom et al Dexamethasone 1mg/ml Suspension Prepared from Crushed Tablets:
Stability in Glass and Plastic Bottles and Plastic Syringes. CJHP 2016; 69 (1).
Supported by:
2. Wen-Lin Chow et al Stability of dexamethasone in extemporaneously prepared oral suspen-
sions. Can J Hosp Pharm 2001;54:96-101
3. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 171—177
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 176—179

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Diazoxide
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Diazoxide 100mg* 10 capsules

X-Temp Pharm-D qs 100 mL

* Remark:
Diazoxide is practically insoluble in water.
Diazoxide solution darkens when expose to light.

2. Procedure (√)

1. Measure out X-temp

2. Empty the capsule content into the mortar.


Add small amount of X-Temp to levigate the powder to form a smooth paste.

3. Gradually add X-temp in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate.
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the syrup into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml

Storage Room temperature


25 ± 2 oC
Keep away from light
Do not freeze
Expiry 90 days

References: Supported by:


1. Friciu M et al Stability of Diazoxide in Extemporaneously Compounded Oral Suspensions.
PLoS One 2016.
2. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 178—181

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Diltiazem
Last updated :______________________
12mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Diltiazem 60mg 10 tablets

X-Temp Pharm-D qs 50 mL

* Remark:
Diltiazem HCl is freely soluble in water. Decomposition occurred at higher pH (7-8)
Optimum pH ~ 5. Choice of sugars as excipients influences the drug stability

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber


plastic bottle 50ml
Storage Room temperature
25 ± 2 oC
Keep away from
light

Expiry 60 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006 Supported by:

2. Ann Pharmacother 2000; 34:848 - 50


3. Paddock Laboratories, Secundum Artem Vol 6 No 1
4. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 127 - 129

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Dipyridamole
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Dipyridamole 25mg 40 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Dipyridamole is soluble in dilute acid solution

2. Procedure (√)

1. Measure out X-temp


2. Wet the tablets with small amount of diluent & leave for a few minutes.
Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber


plastic bottle
100ml
Storage Room temperature
25 ± 2 oC
Stored in the dark

Expiry 60 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006 Supported by:

2. Am J Health Syst Pharm 1996; 53:2179 - 84


3. Paddock Laboratories, Secundum Artem Vol 6 No 1
4. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 132 - 133

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Dolasetron
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Dolasetron mesylate
20 tablets
50mg
X-Temp Pharm-D qs 100 mL
* Remark:
Dolasetron mesylate is a white powder & is freely soluble in water.
Dolasetron mesylate should be stored at controlled room temperature & protected from sunlight.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 90 days
References:
1. Johnson CE, Wagner DS, Bussard WE “Stability of dolasetron in two oral liquid vehicles” Am J
Health-Syst Pharm. 2003;60:2242—44
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 33
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 203

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Domperidone
Last updated :______________________
1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Domperidone 10mg 10 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Domperidone is practically insoluble in water.

2. Procedure (√)

1. Measure out X-temp


2. Wet the tablets with small amount of X-Temp & leave for a few minutes.
Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber


plastic bottle
100ml

Storage Room temperature


25 ± 2 oC

Expiry 91 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
2. International Journal of Pharmaceutical Compounding 2006; 10(1): 61
3. Sick Kids Pharmacy Formulation Sheet, (updated Feb 008)

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Domperidone
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Domperidone 10mg Ranbaxy 50 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Domperidone is practically insoluble in water.

2. Procedure (√)

1. Measure out X-temp


2. Wet the tablets with small amount of X-Temp & leave for a few minutes.
Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber


plastic bottle
100ml

Storage Room temperature


25 ± 2 oC

Expiry 91 days

References:
1. Lingertat-Walsh K, Sales P et al Stability of Extemporaneously Compounded Domperidone Supported by:
5mg/ml Suspension. Department of Pharmacy, The Hospital for Sick Children, Toronto and Sunny-
brook Health Sciences Center, Toronto.
2. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 204

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Domperidone
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Domperidone 10mg 100 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Domperidone is practically insoluble in water.

2. Procedure (√)

1. Measure out X-temp


2. Wet the tablets with small amount of X-Temp & leave for a few minutes.
Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber


plastic bottle
100ml

Storage Room temperature


25 ± 2 oC

Expiry 91 days

References: Supported by:


1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006
2. International Journal of Pharmaceutical Compounding 2006; 10(1): 61

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Enalapril
Last updated :______________________
1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Enalapril 20mg
5 tablets
(maleate)
X-Temp Pharm-D qs 100 mL
* Remark:
An aqueous solubility of enalapril maleate around 25mg/ml at room temperature

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber


plastic bottle
100ml
Storage Room temperature
25 ± 2 oC
Stored in the dark

Expiry 90 days

References:
1. Friciu M et al Stability of Extemporaneously Prepared Enalapril Maleate Suspensions in Glass
Bottles and Plastic Syringes. CJHP 2016; 69 (6)
2. Am J Health Syst Pharm 1998; 55:1915 - 20
Supported by:
3. Paddock Laboratories, Secundum Artem Vol 6 No 2
4. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006
5. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 138 - 140

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Ethambutol
Last updated :______________________
100mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Ethambutol 400mg 25 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Ethambutol is a white crystalline powder. It is freely soluble in water with solubility of 1mg/ml. A 2% aqueous
solution of Ethambutol HCl has a pH of 3.7—4.0.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablet to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle

6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 28 days

Supported by:
References:
1. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 194—199
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 224

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Flecainide acetate
Last updated :______________________
20mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Flecainide Acetate
20 tablets
100mg
X-Temp Pharm-D qs 100 mL
* Remark:
Flecainide acetate is a white hygroscopic crystalline powder & has an aqueous solubility of 48.4mg/ml.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 60 days

References:
1. Am J Health-Syst Pharm. 1996;53:2179—84
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 37
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 236

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Flucytosine
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Flucytosine 250mg 4 capsules

X-Temp Pharm-D qs 100 mL


* Remark:
Flucytosine is a white odorless crystalline powder & is sparingly soluble in water, having an aqueous solubility
of about 1.5g in 100ml.

2. Procedure (√)

1. Measure out X-temp


2. Carefully empty the capsules content into the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 60 days

References:
1. Am J Health-Syst Pharm. 1996;53:1944—99
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 39
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 239

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Flucytosine
Last updated :______________________
50mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Flucytosine 250mg 20 capsules

X-Temp Pharm-D qs 100 mL


* Remark:
Flucytosine is a white odorless crystalline powder & is sparingly soluble in water, having an aqueous solubility
of about 1.5g in 100ml.

2. Procedure (√)

1. Measure out X-temp


2. Carefully empty the capsules content into the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 90 days
References:
1. Vandenbussche H et al. “Stability of flucytosine 50mg/ml in extemporaneous oral liquidformu-
lation” Am J Health-Syst Pharm. 2002;59:1853—55
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 40
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 239

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Folic Acid
Last updated :______________________
1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Folic Acid 5mg Pharmaniaga 20 tablets


X-Temp Pharm-D qs 100 mL
Remark:
Folic acid is very slightly soluble in water; Sensitive to heat & light.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

Special Instruction
3. Sample label : Affix here
Packaging bottle HDPE plastic
bottle 100ml

Storage Room temperature


25 ± 2 oC

Expiry 60 days

Supported by:

Reference:
Local Stability Study in Malaysia at Zone 4 climate. Conducted by Pharm-D Sdn Bhd (22/12/09—
25/02/10)

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments.
MA ST E R F O RM U LA SHE E T Gabapentin
Last updated :______________________
100mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Gabapentin 300mg 20 capsules

X-Temp Pharm-D qs 60 mL
* Remark:
Gabapentin is freely soluble in water.

2. Procedure (√)

1. Measure out X-temp


2. Carefully empty the capsules content into the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging HDPE amber plastic


bottle
bottle 100ml

Storage Room temperature


25 ± 2 oC
(Do Not keep in the fridge)

Expiry 90 days

References:
1. Friciu M et al Stability of Gabapentin in Extemporaneously Compounded Oral Suspensions.
Supported by:
PLoS One 2017
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006
3. Pediatr Neurol 1999 Mar; 20(3): 195-7

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Granisetron Hydrochloride
Last updated :______________________
0.05mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Granisetron 1mg 6 tablets

X-Temp Pharm-D qs 120 mL


* Remark:
Granisetron HCl is a white to off-white solid.
Granisetron HCl is soluble in water & ethanol. Granisetron HCl 1.12mg is equal to Granisetron 1mg.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 90 days

References:
1. Am J Health-Syst Pharm. 1998;55:2511—2513
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 138
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 264

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O MU LA S HE E T Hydrochlorothiazide
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Hydrochlorothiazide
20 tablets
25mg

X-Temp Pharm-D qs 100 mL

* Remark:
Hydrochlorothiazide is a white, odorless crystalline powder. It has a slightly bitter taste.
It is also slightly soluble in water.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE plastic amber


bottle

Storage Room temperature


30 ± 2 oC; 75% RH
Keep away from light

Expiry 120 days

References:
1. Local Stability Study in Malaysia at Zone 4 climate. Conducted by Pharm-D Sdn Bhd (09/10/2017— Supported by:
09/02/2018)
2. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 315-328
3. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 276

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments.
MA ST E R F O RM U LA SHE E T Hydrocortisone
Last updated :______________________
1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Hydrocortisone 10mg 10 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Hydrocortisone is a white, odorless, bitter-tasting crystalline powder. It is very slightly soluble in water, having
an aqueous solubility of about 0.28mg/ml.
The pH range o f maximum stability of hydrocortisone is 3.5 to 4.5.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 91 days

References:
1. Chong G. et al “Stability of hydrocortisone in extemporaneously compounded suspension” Supported by:
J Inform Pharmacother. 2003;13:100-110
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 277
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 43

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Hydrocortisone
Last updated :______________________
2mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Hydrocortisone 10mg 20 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Hydrocortisone is a white, odorless, bitter-tasting crystalline powder. It is very slightly soluble in water, having
an aqueous solubility of about 0.28mg/ml.
The pH range o f maximum stability of hydrocortisone is 3.5 to 4.5.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 91 days

References:
1. Chong G. et al “Stability of hydrocortisone in extemporaneously compounded suspension” Supported by:
J Inform Pharmacother. 2003;13:100-110
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 277
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 44

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Hydroxychloroquine Sulfate
Last updated :______________________
25mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Hydroxychloroquine
15 tablets
200mg

X-Temp Pharm-D qs 120 mL

* Remark:
Hydroxychloroquine sulfate is a white to almost white odorless crystalline powder having a bitter taste.
Hydroxychloroquine sulfate 100mg is approximately equivalent to 77mg of the base. It has a solubility of about
200mg/ml in water.

2. Procedure (√)
1. Measure out X-temp
2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 120ml

Storage Room temperature


25 ± 2 oC

Expiry 90 days

References: Supported by:


1. McHenry A.R et al Stability of Extemporaneously Prepared Hydroxychloroquine Sulfate
25mg/ml Suspensions in Plastic Bottles and Syringes. IJPC 2017; 21 (3)
2. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 284

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Isoniazid
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Isoniazid 100mg Pharmaniaga 10 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Isoniazid is an odorless white crystalline powder. It is soluble in water to about 125 to 140mg/ml at 25 oC.
A 1% aqueous solution has a pH of 5.5 to 6.5. A 10% aqueous solution has a pH between 6.0 –7.5.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber


plastic bottle
100ml

Storage Room temperature


30 ± 2 oC; 75% RH
Keep away from
light
Expiry 90 days

Reference: Supported by:


1. Local Stability Study in Malaysia at Zone IVB climate. Conducted by Pharm-D Sdn Bhd
(04/01/2016—01/04/2016).
2. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 304 - 307.

Disclaimer: the informa!on on this master formula!on sheet is for informa!onal purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
informa!on by any hospitals . Pa!ent circumstances will vary and some informa!on may have become outdated as a result of more recent developments.
MA ST E R F O RM U LA SHE E T Isoniazid
Last updated :______________________
40mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Isoniazid 100mg Pharmaniaga 40 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Isoniazid is an odorless white crystalline powder. It is soluble in water to about 125 to 140mg/ml at 25 oC.
A 1% aqueous solution has a pH of 5.5 to 6.5. A 10% aqueous solution has a pH between 6.0 –7.5.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber


plastic bottle
100ml

Storage Room temperature


30 ± 2 oC; 75% RH
Keep away from
light
Expiry 90 days

Reference: Supported by:

1. Local Stability Study in Malaysia at Zone IVB climate. Conducted by Pharm-D Sdn Bhd
(20/11/2020—18/02/2021).
2. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 304 - 307

Disclaimer: the informa!on on this master formula!on sheet is for informa!onal purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
informa!on by any hospitals . Pa!ent circumstances will vary and some informa!on may have become outdated as a result of more recent developments.
MA ST E R F O RM U LA SHE E T Itraconazole
Last updated :______________________
20mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Itraconazole 100mg 20 capsules

Alcohol USP 7.5ml

X-Temp Pharm-D qs 100 mL


* Remark:
Itraconazole is a white or nearly white powder which is practically insoluble in water.
Itraconazole capsules should be kept away from light & moisture.

2. Procedure (√)

1. Measure out X-temp


2.
Carefully empty the capsules content into the mortar. Add the Alcohol,USP. Let it stand for 5
min. Crush the beads in the mortar and reduce to a fine powder.

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction


Packaging bottle HDPE amber plastic
bottle 100ml
Storage Room temperature
25 ± 2 oC
Keep away from light
Do not freeze

Expiry 56 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
2. Abdel-Rahman SM, Nahata, Stability of Itraconazole in an extemporaneous suspension. J Paed
Pharm Pract. 1998;3:115-8
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 311-312
Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Ketoconazole
Last updated :______________________
20mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Ketoconazole 200mg 10 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Ketoconazole is a white to slightly beige, odorless crystalline powder.
Ketoconazole is practically insoluble in water.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 60 days

References:
1. Am J Health-Syst Pharm. 1996;53:2073—2078
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 62
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 373

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Labetalol
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Labetalol 100mg 12 tablets

X-Temp Pharm-D qs 120 mL

* Remark:
Labetalol HCl has an aqueous stability of about 20mg/ml. Optimum pH 4.0 - 5.0

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber


plastic bottle
150ml
Storage Room temperature
25 ± 2 oC
Stored in the dark

Expiry 60 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006 Supported by:

2. Am J Health Syst Pharm 1996; 53:2304-9


3. Paddock Laboratories, Secundum Artem Vol 6 No 1
4. Lawrence A. Trissel “Stability of Componded Formulations, 2nd Ed” pg 209-211

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Lamotrigine
Last updated :______________________
1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Lamotrigine 100mg 1 tablet

X-Temp Pharm-D qs 100 mL


* Remark:
Lamotrigine is white to pale cream powder that is very slightly soluble in water, having solubility of 0.17mg/ml
at 25o C. Lamotrigine tablets should be stored between 15 and 25o C in a dry place & protected from light

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablet to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 91 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
2. Nahata et al, Stability of lamotrigine in two extemporaneously prepared oral suspensions at 4
and 25oC. Am J Health Syst Pharm 1999;56:240-242
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 321-322

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Levetiracetam
Last updated :______________________
50mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Levetiracetam 500mg 10 tablets

X-Temp Pharm-D qs 100 mL


* Remark:

2. Procedure (√)
1. Measure out X-temp
2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml

Storage Room temperature


25 ± 2 oC

Expiry 95 days

References:
1. Mary H H Ensom, Diane Décarie Stability of Extemporaneously Compounded Levetiracetam in Supported by:
Glass and Plastic Bottles and Plastic Syringes. CJHP 2015; 68 (4).
2. Ensom MHH, Decarie D, Rudolph S. Stability of Levetiracetam in extemporaneously
compounded suspensions. CJHP 2011; 64(3):207-11.

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Lisinopril
Last updated :______________________
1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Lisinopril 10mg 12 tablets

X-Temp Pharm-D qs 120 mL


* Remark:
Lisinopril is a white to off-white odorless crystalline powdr. Lisinopril 2.72mg as the dehydrate is
approximately equivalent to lisinopril anhydrous 2.5mg.
Lisinopril hasan aquoues solubility of 97mg/ml

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC

Expiry 91 days

References:
1. Ann Pharmacother. 2004;38:396—399
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 55
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 336

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Lorazepam
Last updated :______________________
200mcg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Lorazepam 1mg 10 tablet

X-Temp Pharm-D qs 50 mL
* Remark:
Lorazepam is a white odorless crystalline powder. Lorazepam is practically insoluble in water, with a reported
solubility of 0.08mg/ml

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablet to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle Amber Glass bottle


100ml

Storage Fridge temperature


2– 8oC
Keep away from light

Expiry 7 days

References: Supported by:

1. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 255—263


2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 342

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O MU LA S HE E T Melatonin
Last updated :______________________
2mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Melatonin 10mg 50 tablets

X-Temp Pharm-D qs 250 mL


* Remark:

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

Special Instruction
3. Sample label : Affix here
Packaging bottle Plastic amber bottle

Storage Room temperature


25 ± 2 oC

Expiry 90 days

Supported by:

Reference:
Friciu M et al. Evaluation of stability of melatonin in extemporaneously compounded oral suspen-
sions. Journal of Pharmacy Practice and Research , 2016,46: 28-33

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments.
MA ST E R F O RM U LA SHE E T Metolazone
Last updated :______________________
1mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Metolazone 10mg 10 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Metolazone is a quinazoline diuretic, is a white powder.
Metolazone is practically insoluble in water

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 60 days

References:
1. Am J Health-Syst Pharm. 1996;53:2073—2078
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 48
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 374

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Metoprolol
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Metoprolol tartarate
Novartis 24 tablets
50mg (Lopresor)

X-Temp Pharm-D qs 120 mL

* Remark:
Metoprolol tartarate is very soluble in the water

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber


plastic bottle
150ml
Storage Room temperature
25 ± 2 oC
Keep away from
light

Expiry 60 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006 Supported by:

2. Am J Health Syst Pharm 1996; 53:2304-9


3. Paddock Laboratories, Secundum Artem Vol 6 No 1
4. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 248-9

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Metronidazole
Last updated :______________________
50mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Metronidazole powder 6 gram

X-Temp Pharm-D qs 120 mL


* Remark:
Metronidazole is an odorless white to yellow crystalline powder, it has very bitter taste. Metronidazole is
slightly soluble in water, having an aqueous solubility at 20oC of about 10mg/ml. Metronidazole are stable in
air but may darken upon exposure to light.

2. Procedure (√)

1. Measure out X-temp


2. Measure the require amount of powder.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 120ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 60 days

References:
1. Allen LV, Erickson MA, Stability of ketoconazole, metolazone, metronidazole, procainamide Supported by:
hydrochloride, and spironolactone in extemporaneously compounded oral liquids. Am J
Health Syst Pharm. 1996;53:2073-8
2. Secundum Artem Vol 5 No 4
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 376-380

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Metronidazole
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Metronidazole 200mg 6 tablets

X-Temp Pharm-D qs 120 mL


* Remark:
Metronidazole is an odorless white to yellow crystalline powder, it has very bitter taste. Metronidazole is
slightly soluble in water, having an aqueous solubility at 20oC of about 10mg/ml. Metronidazole are stable in
air but may darken upon exposure to light.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablet to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 120ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 90 days

References: Supported by:


1. Mathew M, Gupta VD, Bethea C, Stability of metronidazole in solutions and suspensions
J Clin Pharm Ther. 1994;19:27-9
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 376-380

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O MU LA S HE E T Morphine
Last updated :______________________
10mg/5ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Morphine HCl Fagron GmbH,


200 mg
Trihydrate Germany

X-Temp Pharm-D qs 100 mL


* Remark:
Morphine soluble in water; Stable in pH around 4.8
Solution turn darker when exposed to light (oxidation)

2. Procedure (√)

1. Measure out X-temp


2. Measure the require amount of powder.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

Special Instruction
3. Sample label : Affix here
Packaging bottle HDPE plastic
bottle 100ml

Storage Room temperature


30 ± 2 oC; 75% RH
Should not be freeze

Expiry 12 months

Supported by:

Reference:
Local Stability Study in Malaysia at Zone 4 climate. Conducted by Pharm-D Sdn Bhd in collaboration with
Pusat Perubatan Universiti Kebangsaan Malaysia, PPUKM (01/12/12—02/12/13)

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments.
MA ST E R F O RM U LA SHE E T Mycophenolate Mofetil
Last updated :______________________
50mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Mycophenolate Mofetil
20 tablets
250mg

X-Temp Pharm-D qs 100 mL

* Remark:
This drug has been characterized as a potential TERATOGEN
Mycophenolate mofetil has an aqueous solubility of 43mcg/ml at pH 7.4. Aqueous solubility increases as the
pH becomes more acidic; solubility increases to 4.27mg/ml at pH 3.6.

2. Procedure (√)
1. Measure out X-temp
2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml

Storage Room temperature


25 ± 2 oC

Expiry 91 days

References:
1. Mary H H Ensom, Diane Décarie Stability of Mycophenolate Mofetil in a 1:1 Mixture of Ora- Supported by:
Sweet and Ora-Plus CJHP 2002; 55 (1).
2. Venkataramanan R et al Stability of Mycophenolate Mofetil as an extemporaneous suspen-
sion. Ann Pharmacother 1998; 32:755-7

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Mycophenolate Mofetil
Last updated :______________________
100mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Mycophenolate Mofetil
40 tablets
250mg

X-Temp Pharm-D qs 100 mL

* Remark:
This drug has been characterized as a potential TERATOGEN
Mycophenolate mofetil has an aqueous solubility of 43mcg/ml at pH 7.4. Aqueous solubility increases as the
pH becomes more acidic; solubility increases to 4.27mg/ml at pH 3.6.

2. Procedure (√)
1. Measure out X-temp
2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml

Storage Room temperature


25 ± 2 oC

Expiry 91 days

References:
1. Mary H H Ensom, Diane Décarie Stability of Mycophenolate Mofetil in a 1:1 Mixture of Ora- Supported by:
Sweet and Ora-Plus CJHP 2002; 55 (1).
2. Anaizi NH et al Stability of mycophenolate mofetil in an extemporaneously compounded
oral liquid. Am J Health Syst Pharm 1998; 55:926-9

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Naproxen
Last updated :______________________
25mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Naproxen 250mg 10 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Naproxen acid is practically insoluble in water at low pH but is freely soluble at high pH.
The milky, pale yellow suspensions were easily re-suspended.

2. Procedure (√)
1. Measure out X-temp.
2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste.
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate.
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well.
5. Transfer the suspension into bottle.
6. Label and affix shrink seal.

3. Sample label : Affix here


Special Instruction
Packaging bottle HDPE amber plastic
bottle 100ml

Storage Room temperature


25 ± 2 oC

Expiry 91 days

References:
Supported by:
1. Mary H H Ensom, Diane Décarie, Karen Lingertat-Walsh “Stability of Extemporaneously Com-
pounded Naproxen 25 mg/mL Suspension in Glass and Plastic Bottles and Plastic Syringes.”
The Canadian Journal of Hospital Pharmacy (CJHP) 2015, 68(6):489-491.
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 402.

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Naratriptan Hydrochloride
Last updated :______________________
0.5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Naratriptan 2.5mg 24 tablets

X-Temp Pharm-D qs 120 mL


* Remark:
Naratriptan HCl is a white to pale yellow crystalline powder.
Naraptriptan HCl is readily soluble in water.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Fridge temperature
2 - 8 oC

Expiry 90 days

References:
1. Int J Pharm Compound 2000;4:69—71
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 69
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 403

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Nifedipine
Last updated :______________________
4mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Nifedipine 10 mg Novopharm 25 capsules

X-Temp Pharm-D qs 60 mL
* Remark:
Nifedipine is practically insoluble in water; light-sensitive
Nifedipine liquid-filled capsules should be packed in tight, light-resistant containers & stored between 15 and
25oC. The extended-release tablets may be stored in room temperature.

2. Procedure (√)

1. Measure out X-temp


2. Carefully empty the liquid-filled capsules into the mortar, using needle & syringe, 2-hole
method. With care and two repetitions per capsule, abot95% of the liquid will be removed.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction


Packaging bottle HDPE amber plastic
bottle 100ml

Storage Room temperature


25 ± 2 oC
Store in the dark

Expiry 91 days

Supported by:

References:
1. Secundum Artem Vol 14 No 4
2. Trissel’s “Stability of Compunded Formulations, 4th Ed” pg 406—409

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Nitrofurantoin
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Nitrofurantoin 50mg 20 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Nitrofurantoin is slightly soluble in water. Nitrofurantoin oral suspension has pH between 4.5 - 6.5.
Nitrofurantoin is stable over a wide pH range from 5.4-9.9; Turns dark when prolonged exposure to light
Nitrofurantoin decomposes when in contact with metal other than aluminum or stainless steel.

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction


Packaging HDPE amber
bottle
plastic bottle 100ml

Storage Room temperature


25 ± 2 oC
Keep away from light
Do not freeze

Expiry 90 days

References:
Supported by:
1. Mary H.H. Ensom et al, Stability of Nitrofurantoin in Extemporaneously Compounded Suspen-
sions. Can J Hosp Pharm 2006;59: 29-33
2. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 273-274
3. Sick Kids Pharmacy Formulation Sheet (updated April 2007)

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Ondansetron
Last updated :______________________
0.8mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Ondansetron HCl 8mg 10 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Ondansetron hydrochloride is a white to off-white powder that is soluble in water. 1.25mg Ondansetron HCl
provides approximately 1mg of Ondansetron base. The natural pH of Ondansetron HCl in aqueous solution is
about 4.5. If the solution pH increases above the range of 5.7—7.0, a precipitate of free Ondansetron base
develops. Precipitation will redissolve if the solution is retitrated with HCl acid.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablet to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml
Storage Fridge temperature
2– 8oC
Keep away from light

Expiry 42 days

Supported by:
References:
1. William Cl, Sanders PL, Laizure SC, et al “ Stability of Ondansetron Hydrochloride in syrups
compounded from tablets” Am J Hosp Pharm 1994;51:806-809.
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 421

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Oseltamivir
Last updated :______________________
15mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Oseltamivir
12 capsules
Phosphate 75mg

X-Temp Pharm-D qs 60 mL
* Remark:
White crystalline Oseltamivir phosphate have bitter taste, very soluble in water with aqueous solubility of
588mg/ml at 25oC

2. Procedure (√)

1. Measure out X-temp


2. Carefully empty the capsules content into the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal
3. Sample label : Affix here
Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 35 days

References:
Supported by:
1. Winiarski K, Infeld MH, Tsherne R et al “Preparation & Stability of Extemporaneous oral liquid
formulations of Oseltamivir using commercially available capsules” - J Am Pharm Assoc.
2007;47:747-55
2. Secundum Artem Vol 16 No13

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Phenobarbitone
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Phenobarbital
Idaman Pharma 20 tablets
30mg*

X-Temp Pharm-D qs 60 mL
* Remark:
Phenobarbital is an odorless white crystalline powder having a bitter taste.
Phenobarbital is very slightly soluble in water, having aqueous solubility of about 1mg/ml

2. Procedure (√)
1. Measure out X-temp
2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber


plastic bottle
100ml
Storage Room temperature
30 ± 2 oC; 75% RH
Keep away from
light

Expiry 6 months

References: Supported by:

1. Local Stability Study in Malaysia at Zone 4 climate. Conducted by Pharm-D Sdn Bhd (06/08/2014—
02/02/2015)
2. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 315-328

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Prednisone
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Prednisone 5mg
100 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Prednisone is a white, odorless crystalline powder. It is very slightly soluble in water. In ethanol it has
solubility of about 6.7mg/ml. The syrup has a pH between 3.0 and 4.5.

2. Procedure (√)
1. Measure out X-temp.
2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste.
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate.
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well.
5. Transfer the suspension into bottle.
6. Label and affix shrink seal.

3. Sample label : Affix here


Special Instruction
Packaging bottle HDPE plastic
amber bottle 100ml

Storage Room temperature


25 ± 2 oC

Expiry 90 days

References:
Supported by:
1. Friciu M, Plourde K, Leclair G, Danopoulos P, Savji T “Stability of Prednisone in Oral Mix Sus-
pending Vehicle.” International Journal of Pharmaceutical Compounding (IJPC) 2015, 19(4):337 –
339.
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 467.

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Procainamide
Last updated :______________________
50mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Procainamide 250mg 20 capsules

X-Temp Pharm-D qs 100 mL


* Remark:
Procainamide HCl is a white hygroscopic, odorless crystalline powder. Procainamide HCL is very soluble in
water, with an aqueous solubility of about 4g/ml.
Procainamide should be protected from light. Exposure to air causes darkening of the solution.

2. Procedure (√)

1. Measure out X-temp


2. Carefully empty the capsules content into the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 60 days

References:
1. Am J Health-Syst Pharm. 1996;53:2073—78
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 469

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Propranolol
Last updated :______________________
2mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement
Propranolol 40mg
5 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Propranolol HCl is a white to off-white odorless crystalline powder having a bitter taste. Propranolol HCl is
soluble in water and ethanol, with solubility around 50mg/ml.
The pH of maximum stability was reported to be 2.8 to 4. The drug undergoes rapid decomposition in alkaline
solution.

2. Procedure (√)

1. Measure out X-temp.


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste.
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate.
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well.
5. Transfer the suspension into bottle.
6. Label and affix shrink seal.

3. Sample label : Affix here


Special Instruction
Packaging bottle HDPE plastic
amber bottle 100ml

Storage Room temperature


25 ± 2 oC

Expiry 120 days

References:
Supported by:
1. Mary H.H. Ensom et al “Stability of Propranolol in Extemporaneously Compounded
Suspensions” Can J Hosp Pharm 2013; 66(2):118-124
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 478.

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Propranolol
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Propranolol 40mg 15 tablets

X-Temp Pharm-D qs 120 mL

* Remark:
Propranolol HCl is a white to off-white odorless crystalline powder having a bitter taste. Propranolol HCl is
soluble in water and ethanol, with solubility around 50mg/ml.
The pH of maximum stability was reported to be 2.8 to 4. The drug undergoes rapid decomposition in alkaline
solution.

2. Procedure (√)

1. Measure out X-temp.


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste.
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate.
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well.
5. Transfer the suspension into bottle.
6. Label and affix shrink seal.

3. Sample label : Affix here


Special Instruction
Packaging bottle HDPE plastic
amber bottle 100ml

Storage Room temperature


25 ± 2 oC

Expiry 120 days

References:
Supported by:
1. Mary H.H. Ensom et al “Stability of Propranolol in Extemporaneously Compounded
Suspensions” Can J Hosp Pharm 2013; 66(2):118-124
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 478.

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Propylthiouracil
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Propylthiouracil 50mg 10 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Propylthiouracil is a white powder having a bitter taste & a starch-like appearance. It has an aqueous
solubility of about 1.1mg/ml

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Fridge temperature
2 - 8 oC

Expiry 91 days

References:
1. Am J Health-Syst Pharm. 2000;57:1141—43
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 79
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 481

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Pyrazinamide
Last updated :______________________
100mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Pyrazinamide 500mg 20 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Pyrazinamide is sparingly soluble in water

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber


plastic bottle
100ml
Storage Room temperature
25 ± 2 oC
Keep away from
light

Expiry 60 days

References:
Supported by:
1. Am J Health Syst.Pharm 55(17): 1804-1809,1998
2. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 344-350
3. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Quinidine Sulfate
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Quinidine 200mg 5 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Quinidine sulphate is a white, odorless, crystalline powder having a bitter taste.
Quinidine sulfate dehydrate 241mg & Quinidine sulfate anhydrous 230mg are approximately equivalent to
Quinidine anhydrous 200mg. Quinidine sulfate has an aqueous solubility of about 10mg/ml.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC

Expiry 60 days

References:
1. Am J Health-Syst Pharm. 1998;55:1804—1809
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 83
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 489

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Rifabutin
Last updated :______________________
20mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Rifabutin 150mg 4 capsules

X-Temp Pharm-D qs 30 mL

* Remark:
Rifabutin is very slightly soluble in water having aqueous stability of about 0.19mg/ml.

2. Procedure (√)

1. Measure out X-temp


2. Carefully empty the capsules content into the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic


bottle 50ml

Storage Room temperature


25 ± 2 oC

Expiry 84 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006 Supported by:

2. Am J Health Syst Pharm 1999; 56:333-6


3. Paddock Laboratories Secundum Artem Vol 15 No 1
4. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 336

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Rifampicin
Last updated :______________________
25mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Rifampicin 300mg
Rifasynt 10 capsules
capsules

X-Temp Pharm-D qs 120 mL

* Remark:
Rifampicin slightly soluble in water; Oxidation occurred at alkali pH, can be slowed by addition of Ascorbic
acid

2. Procedure (√)

1. Measure out X-temp


2. Open & carefully empty the content of capsules into mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well

5. Transfer the suspension into bottle


6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE amber


plastic bottle
120ml

Storage Room temperature


30 ± 2 oC; 75% RH
Keep away from
light

Expiry 90 days

References: Supported by:

1. Md Salim et. al Stability of extemporaneous rifampicin prepared with X-Temp oral suspension
system. Journal of Pharmacy IIUM 1(1), 54-62.
https://journals.iium.edu.my/ktn/index.php/jp/article/view/42/22
2. Am J Health Syst Pharm, 55 (17):1804 –1809,1998
Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
M A S TE R F O M U L A S H E E T Sildenafil
Last updated :______________________
2.5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Sildenafil 50mg
5 tablets
(citrate)

X-Temp Pharm-D qs 100 mL

* Remark:
Solubility of Sildenafil is 3.5mg/ml

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction


Packaging bottle HDPE plastic
bottle 50ml

Storage Room temperature


25 ± 2 oC

Expiry 91 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
2. Am J Health Syst.Pharm 2006; 63: 254-7
3. Paddock Laboratories Secundum Artem Vol 14 No 1
4. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 363-367

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X‐Temp as the vehicle though X‐Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X‐Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Sodium Phenylbutyrate
Last updated :______________________
200mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Vetyrate 5g Pharm-D 4 sachets

X-Temp Pharm-D qs 100 mL


* Remark:
Sodium Phenylbutyrate is an off-white crystalline powder. 1gram of oral powder provides 0.94gram of sodium
butyrate or 3gram of sodium butyrate per 3.2gram of powder. Sodium Butyrate is very soluble in water,
500mg/ml. The excipients in the tablets & oral powder are much less soluble in water than in sodium
butyrate

2. Procedure (√)

1. Measure out X-temp


2. Weigh the amount of powder and ground to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic


bottle 120ml

Storage Room temperature


25 ± 2 oC

Expiry 90 days

References:
Supported by:
1. Caruthers RL, Johnson CE “Stability of extemporaneously prepared sodium phenylbutyrate
oral suspensions” Am J Health Syst Pharm. 2007;64:1513-5
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 510
3. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 377—379

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
M A S TE R F O M U L A S H E E T Sotalol
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Sotalol 80mg
5 tablets
(hydrochloride)

X-Temp Pharm-D qs 80 mL

* Remark:
Sotalol HCl is freely soluble in water

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction


Packaging bottle HDPE plastic
bottle 100ml

Storage Fridge temperature


2 – 8 oC

Expiry 84 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006 Supported by:

2. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 347-348


3. Sick Kids Pharmacy Formulation Sheet (updated April 2007)
4. Paddock Laboratories Secundum Artem Vol 14 No 3

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X‐Temp as the vehicle though X‐Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X‐Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Spironolactone
Last updated :______________________
1.25mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Spironolactone 25mg Pharmaniaga 5 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Spironolactone tablet is insoluble in water & stable at pH about 4.5

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE plastic


bottle 100ml

Storage Room temperature


25 ± 2 oC

Expiry 60 days

Supported by:
Reference:
Local Stability Study in Malaysia at Zone 4 climate. Conducted by Pharm-D Sdn Bhd (29/12/09—
25/02/10)

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments.
MA ST E R F O RM U LA SHE E T Spironolactone
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Spironolactone 25mg Remedica 20 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Spironolactone tablet is insoluble in water & stable at pH about 4.5

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here


Special Instruction

Packaging bottle HDPE plastic


amber bottle

Storage Room temperature


30 ± 2 oC; 75% RH

Expiry 180 days

Reference: Supported by:

1. Local Stability Study in Malaysia at Zone 4B climate. Conducted by Pharm-D Sdn Bhd (10/10/2017
—09/04/2018).
2. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 515

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments.
MA ST E R F O RM U LA SHE E T Sulfasalazine
Last updated :______________________
100mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Sulfasalazine 500mg Pharm-D 24 tablets

X-Temp Pharm-D qs 120 mL


* Remark:
Sulfasalaine is bright yellow or brownish yellow fine powder. It is practically insoluble in water. It should be
protected from sun light. The suspension pH is about 4.4.
Do avoid use enteric-coated tablets.

2. Procedure (√)

1. Measure out X-temp


2. Weigh the amount of tablet and ground to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 120ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 91 days

References:
1. Lingertat-Walsh K, Walker SE, Law S et al “Stability of Sulfasalazine oral suspension” Can J Supported by:
Hosp Pharm. 2006;59:194-200
2. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 94
3. Secundum Artem Vol 14 No 3
Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Tacrolimus
Last updated :______________________
0.5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Tacrolimus 5mg 6 capsules

X-Temp Pharm-D qs 60 mL
* Remark:
Tacrolimus is practically insoluble in water (1-2mcg/ml)Tacrolimus exhibits maximm stability at pH 2-6;
higher pH will increase degradation rate.

2. Procedure (√)
1. Measure out X-temp
2. Grind the tablet to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction


Packaging bottle Amber glass bottle
120ml
Do not use PVC bottle
Storage Room temperature
25 ± 2 oC
Shake well before use.
Expiry 90 days

References:
1. Friciu M et al.“Stability of Extemporaneously Compounded Tacrolimus in Glass Bottles and
Plastic Syringes.” Can J Hosp Pharm 70(1),2017
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006 Supported by:
3. Jacobson PA et al, Stability of Tacrolimus in an extemporaneously compounded oral liquid. Am
J Health Syst Pharm 1997;54:178-80
4. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 103-109
5. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 526-528

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Terbinafine
Last updated :______________________
25mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Terbinafine 250mg 10 tablets

X-Temp Pharm-D qs 100 mL

* Remark:
Terbinafine is slightly soluble in water

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml
Do not freeze
Storage Room temperature
25 ± 2 oC
Keep away from light

Expiry 42 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006 Supported by:

2. Lawrence A. Trissel “Stability of Compounded Formulations, 2nd Ed” pg 360


3. Am J Health Syst Pharm 1999; 56:243-5
4. Paddock Laboratories Secundum Artem Vol 15 No 1

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Theophylline
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Theophylline 300mg 1 tablet

X-Temp Pharm-D qs 60 mL
* Remark:
Theophylline is a white odorless crystalline powder with bitter taste. It has an aqueous solubility of about
8.3mg/ml. Oral suspension of theophylline can be extemporaneously prepared from bulk, USP, powder and
also from crushed theophylline extended-release tablets. The formula from bulk powder was most palatable,
while from the crushed tablets was the least palatable, though it was still acceptable .

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablet to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Gradually add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed.
Transfer the contents into the graduate. Use additional vehicle to rinse the remaining drug from
the mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 90 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
2. Johnson CE et al, Stability of anhydrous theophylline in extemporaneously prepared alcohol-
free oral suspensions. Am J Health Syst Pharm 2005;62:2518-20
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 542-544

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Thiamine
Last updated :______________________
20mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Thiamine 100mg 20 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Solubility of Thiamine is 1g/ml. Rapid deconstruction of thiamine occurs if pH of the solution is above 5.5.
For longer shelf-life, powder form is preferred than tablets form. Beyond-used-date for thiamine suspension
using powder can last up to 91 days in room temperatures.

2. Procedure (√)

1. Measure out X-temp


2. Carefully empty the capsules content into the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal
3. Sample label : Affix here
Special Instruction

Packaging bottle HDPE amber plastic


bottle 100ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 28 days

References: Supported by:

1. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 396—403


2. Secundum Artem Vol 14 No 3
3. Can J Hosp Pharm 2005; 58:26-30

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Tramadol
Last updated :______________________
5mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Tramadol 50mg 12 tablets

X-Temp Pharm-D qs 120 mL


* Remark:
Tramadol HCl is a white bitter odorless crystalline powder.
Tramadol HCl is readily soluble in water

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml
Storage Room temperature
25 ± 2 oC

Expiry 90 days

References:
1. Am J Health-Syst Pharm. 2003;60:1268—1270
2. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 105
4. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 559

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Trimethoprim
Last updated :______________________
10mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control


Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement
Trimethoprim 100mg
10 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Trimethoprim occurs as white to cream-colored odorless bitter-tasting crystals. Trimethoprim is very slightly
soluble in water, having an aqueous solubility of about 0.4mg/ml.

2. Procedure (√)

1. Measure out X-temp.


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste.
3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate.
4. Make up the final volume in the graduated using more X-temp vehicle. Stir well.
5. Transfer the suspension into bottle.
6. Label and affix shrink seal.

3. Sample label : Affix here Special Instruction


Packaging bottle HDPE plastic
amber bottle 100ml

Storage Room temperature


25 ± 2 oC

Expiry 92 days

References:
1. Mary H.H. Ensom et al “Stability of Extemporaneously Compounded Trimethoprim in Glass
and Plastic Bottles and Plastic Syringes” Can J Hosp Pharm 2016, 69(2):171-173. Supported by:

2. Nahata MC. “Stability of Trimethoprim in an extemporaneous liquid dosage form” J Pediatrr


Pharm Pract. 1997;2:82-84
3. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 568.

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Ursodeoxycholic
Last updated :______________________
25mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

10 capsules
Ursodeoxycholic 300mg

X-Temp Pharm-D qs 120 mL

* Remark:
Ursodeoxycholic acid is a naturally occurring bile acid that is white crystalline powder having a bitter taste.
Ursodeoxycholic is practically insoluble in water.

2. Procedure (√)

1. Measure out X-temp


2. Carefully empty the capsules content into the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber


plastic bottle

Storage Room temperature


23 - 25 oC

Expiry 60 days

References:
1. Mallet MS et al, Stability of ursodiol 25mg/ml in an extemporaneously prepared oral liquid.
Am J Health Syst Pharm. 1997;54:1401-1404. Supported by:

2. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 574


3. Sick Kids Pharmacy Formulation Sheet (updated April 2007)
4. Paddock Laboratories Secundum Artem Vol 14 No 3

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Ursodeoxycholic
Last updated :______________________
50mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

20 tablets
Ursodeoxycholic 250mg

X-Temp Pharm-D qs 100 mL

* Remark:
Ursodeoxycholic acid is a naturally occurring bile acid that is white crystalline powder having a bitter taste.
Ursodeoxycholic is practically insoluble in water.

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the
mortar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE amber


plastic bottle
100ml
Storage Room temperature
23 - 25 oC

Expiry 90 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared Supported by:
from commercially available products. JPPS 9(3): 398-426,2006
2. Johnson C.E and Streetman D.D. Stability of oral suspensions of ursodiol made from tablets.
Am J Health Syst Pharm 59(4):361-363,2002
3. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 574

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Valganciclovir
Last updated :______________________
60mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Valganciclovir 450mg 16 tablets

X-Temp Pharm-D qs 120 mL

Remarks:
Valganciclovir HCl is a white crystalline powder. It has an aqueous solubility of 70mg/ml.
Valganciclovir was found to be most stable at pHvalues of 3.5 and lower.
CYTOTOXIC– Must use designated cytotoxic equipment and prepare in segregated area. Wear protective
equipment

2. Procedure (√)

1. Measure out X-temp


2. Wet the tablets with small of X-Temp before crushing the tablet to prevent exposure to medicine
powder. Crush the tablets to form a smooth paste.

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal. Additional label: Cyctotoxic

3. Sample label : Affix here Special Instruction

Packaging bottle Glass amber bottle

Storage Fridge temperature


2– 8oC

Expiry 35 days

References:
1. Beverley D Glass, Stability consideration in liquid dosage forms extemporaneously prepared
from commercially available products. JPPS 9(3): 398-426,2006
Supported by:
2. Am J Health Syst.Pharm 2003; 60: 687-90
3. Rita K Jew, Winson Soo-Ho, Sarah C Erush “Extemporaneous Formulations for Pediatric, Geriatric,
and Special Needs Patients” 2nd Ed pg 161
4. Paddock Laboratories Secundum Artem Vol 14 No 3

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Verapamil
Last updated :______________________
50mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________

Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Verapamil 80mg 75 tablets

X-Temp Pharm-D qs 120 mL

* Remark:
Verapamil HCl is white, nearly odorless crystalline powder having a bitter taste. It is soluble in water. The
Injection should be protected from light & freezing. Maximum stability occurs in the pH range of 3.2 - 5.6.

2. Procedure (√)

1. Measure out X-temp


2. Crush the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic


bottle 50ml

Storage Room temperature


25 ± 2 oC

Expiry 91 days

References:
1. Allen LV, Erickson MA “Stability of labetolol hydrochloride, metoprolol tartarate, verapamil
hydrochloride and spironolactone with hydrochlorothiazide in extemporaneously Supported by:
compounded oral liquids.” Am J Health Syst Pharm. 1996;53:2304-9
2. Paddock Laboratories Secundum Artem Vol 6 No 1
3. Lawrence A. Trissel “Stability of Compounded Formulations, 4th Ed” pg 584

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.
MA ST E R F O RM U LA SHE E T Warfarin
Last updated :______________________
0.2mg/ml Oral Suspension
Updated by :_______________________

Hospital :_______________________
Batch No.: Batch Size: Date Prepared: EXP date: Prepared by: Final Checked by:

1. Raw Materials Quality Control

Grade/ Quantity/
Ingredients Batch no. EXP date Measured by Checked by
Manufacturer measurement

Warfarin 5mg 4 tablets

X-Temp Pharm-D qs 100 mL


* Remark:
Warfarin Sodium is a white odorless amorphous hygroscopic powder with slightly bitter taste.
Warfarin sodium is very soluble in water, having solubilities greater than 1g/ml. Warfarin sodium is
discoloured by light and have to be protected from excessive temperatures of 40oC or more.

2. Procedure (√)

1. Measure out X-temp


2. Grind the tablets to fine powder in the mortar.
Add small amount of X-Temp to levigate the powder to form a smooth paste

3. Add X-temp vehicle in small amounts to the paste, mix well until a liquid is formed. Transfer
the contents into the graduate. Use additional vehicle to rinse the remaining drug from the mor-
tar and add to the graduate

4. Make up the final volume in the graduated using more X-temp vehicle. Stir well
5. Transfer the suspension into bottle
6. Label and affix shrink seal

3. Sample label : Affix here Special Instruction

Packaging bottle HDPE plastic amber


bottle 120ml

Storage Room temperature


25 ± 2 oC
Keep away from light

Expiry 7 days

References:
Supported by:
1. M. Jackson & A. Lowey “Handbook of Extemporaneous Preparation” pg 415
2. Trissel’s “Stability of Compounded Formulations, 4th Ed” pg 591

Disclaimer: the information on this master formulation sheet is for informational purposes for qualified health care professionals. We will not assume responsibility for any errors or omissions, and/or any consequences arising from the use of the
information by any hospitals . Patient circumstances will vary and some information may have become outdated as a result of more recent developments. We have no information on using X-Temp as the vehicle though X-Temp concept was developed
based on an established Oral Suspending Vehicle in USA. It would be up to the compounder’s professional judgment to use X-Temp as a possible alternative.

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