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QC of Solid dosage forms Part 2

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37 views21 pages

QC of Solid dosage forms Part 2

Uploaded by

amanfatima
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Quality Control Of Solid Dosage

Forms- PART 2
Pharmaceutics-VIA
(Pharmaceutical Quality Management)
By
Rabia Khokhar
Weight Variation
OR
Uniformity of Weight (Mass)
(Ph. Eur. method 2.9.5)

• Weigh individually 20 units taken at random OR for single-dose preparations


presented in individual containers, take the contents of 20 units, and
determine the average mass.
• CRITERIA:
 Not more than 2 of the individual masses deviate from the average mass
by more than the percentage deviation and
 None deviates by more than twice that percentage.
How will you perform it in lab???
Weigh 20 tablets individually

Calculate average
weight

Calculate limits Find deviation of


(allowed) individual tablets

Find % deviation of
individual tablets

The results should


lie within limit!
Observations & Calculations:
Weight of 20 tablets= ____
Av. wt. of 20 tablets= X*= ____
Max. limit= X* + (X* x % limit)
Min. limit= X* - (X* x % limit)
Limit (Range)= ______
Weight of tablet Deviation % Deviation
Sr. No.
(X) (D= X*- X) (D/X* x 100)
1
2
.
.
.
20
According to BP
ACTIVITY TIME
• Lets try calculating the percentage deviation for
the following case:

U=132
L= 108 120 mg
300 mg
500 mg
Diameter and Thickness
Obtained reading = Main scale reading + Vernier scale reading
Chemical tests:
 Content uniformity
 Dissolution
 Assay of API
• To ensure the consistency of dosage units, each unit in a batch
should have a drug substance content within a narrow range
around the label claim.
• Dosage units are defined as dosage forms containing a single dose
or a part of a dose of drug substance in each unit.
• The term “uniformity of dosage unit” is defined as the degree of
uniformity in the amount of the substance(s) among dosage units.
• The uniformity of dosage units can be demonstrated by either of
two methods,
– Weight Variation
– Content Uniformity
Content Uniformity
• The test for Content Uniformity is based on the assay of the
individual content of drug substance in a number of individual
dosage units to determine whether the individual content is within
the limits set.
• This test is used to confirm that every unit should contain same
amount of drug or active ingredients with little variation in the
batch.
• 9 OUT OF 10 units should be within 15% range
• The test for Content Uniformity is required for those dosage forms
described in (C1)–(C6) the following:
• Principle
The test of the uniformity of the content of single dose
preparations is based on the assay of individual contents of active
substance(s) of a number of dosage units to determine whether the
individual contents are within the limits set with reference to the
average content of the sample.
• Method
- Using a suitable analytical method, determine the individual
contents of active substance(s) of 10 dosage units taken at random.
- Now apply the criteria of Test A, Test B or Test C as specified in
the monograph for any specified dosage form.
Test A
• For tablets, powders for parenteral use, ophthalmic inserts suspension for
injection.
• The preparation complies with or PASS the test if:
– each individual content is between 85-115% of the Average content.
• The preparation FAILS to comply with the test if:
– more than 1 individual content is outside 85-115% of the average content or if
1 individual content is outside 75-125% of the average content.
– If 1 individual content is outside the limit of 85-115% but within the limit of 75-
125%, determine the individual content of another 20 dosage units taken at
random
• The preparation complies with the test if more than 1 individual content of the 30 units is
outside 85-115% of the average content and none is outside the limit of 75- 125% of the
average content.
Test B
• For capsules, powders other than parenteral use, granules,
suppositories, pessaries.
• PASS or Complies with test if
– not more than 1 individual content is outside 85-115% of the average
content and none is outside the limit of 75-125% of the average content.
• FAILS to comply with test if
– more than 3 individual contents are outside 85-115% of the average
content or if 1 or more individual contents are outside the limit of 75-125%
of the average content.
– If 2 or 3 individual are outside the limit of 85-115% than take 20 more
units and perform as in Test A.
Test C
• For transdermal patches.
• Complies with test if
– average content of 10 dosage units is between the limit of 90- 110%
of the content stated on the label and if the individual content of
each dosage unit is between the limit of 75-125% of the average
content.
ACTIVITY TIME

• I am known as
BLOOM’S STRENGTH,
who am I?????

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