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1 Data Sheet (EA 50% SF)

All-rac-α-Tocopheryl Acetate Powder 50% SF is a white or slightly greenish-yellow powder consisting of finely dispersed all-rac-α-tocopheryl acetate in silicon dioxide. It meets specifications for identification tests, purity levels, assay, and microbial limits according to FCC, USP and Ph. Eur. standards. The product should be stored protected from light, heat, oxygen and moisture at room temperature, and is suitable for use in manufacturing low-content tablets and capsules.

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Selviani Dwi Muryanti
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64 views3 pages

1 Data Sheet (EA 50% SF)

All-rac-α-Tocopheryl Acetate Powder 50% SF is a white or slightly greenish-yellow powder consisting of finely dispersed all-rac-α-tocopheryl acetate in silicon dioxide. It meets specifications for identification tests, purity levels, assay, and microbial limits according to FCC, USP and Ph. Eur. standards. The product should be stored protected from light, heat, oxygen and moisture at room temperature, and is suitable for use in manufacturing low-content tablets and capsules.

Uploaded by

Selviani Dwi Muryanti
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
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all-rac-α-Tocopheryl Acetate Powder 50% SF

EA 50% SF

Data Sheet
Product Description
All-rac-α-Tocopheryl Acetate Powder 50% SF is a white or almost-white to slightly greenish-yellow
free-flowing powder, the individual particles of all-rac-α-tocopheryl acetate are finely dispersed in
silicon dioxide.

Product Identification

Synonym Tocopheryl acetate


CAS No. 7695-91-2
EINECS No. 231-710-0
INCI name Tocopheryl acetate
Chemical Structure

Chemical Formula: C31H52O3 Molecular Weight: 472.75

Specifications

Items Specifications Test Method


White or almost white to slightly greenish-
1 Appearance Visual
yellow free-flowing powder
2 Identification
USP
2.1 Coloration reaction Positive
USP<781>
2.2 Optical rotation -0.01o~+0.01o
USP<621>
2.3 GC
Conforms to the reference solution. Ph.Eur.2.2.28

The position and size of the principal spot Ph.Eur.2.2.27


2.4 TLC corresponds to that of the reference
solution.
USP<731>
3 Loss on drying ≤5.0%
Ph.Eur.2.2.32
USP<233>
4# Lead ≤0.5ppm ICP-MS
USP<233>
5# Arsenic ≤1.5ppm
ICP-MS

Zhejiang Medicine Co.,Ltd. Xinchang Pharmaceutical Factory Product code: 4101152


Tel.: +86-575-86126668 Page 1 of 3 Date: 04-26-2022
Fax: +86-575-86131771 Version No.: 010.4
all-rac-α-Tocopheryl Acetate Powder 50% SF
EA 50% SF

USP<233>
6# Mercury ≤0.1ppm
ICP-MS
USP<233>
7# Cadmium ≤0.5ppm
ICP-MS
≥50.0% USP<621>
8 Assay (GC)
≥225.0 mg α-tocopherol/g Ph.Eur.2.2.28
9 Microbial tests
9.1 Total aerobic microbial count ≤1000 cfu/g USP<2021>
9.2 Total moulds and yeasts count ≤100 cfu/g Ph.Eur.2.6.12
USP<2021>
9.3 Enterobacteria ≤10 cfu/g
Ph.Eur.2.6.13
9.4* Salmonella n.d./25g
9.5* Escherichia coli n.d./10g USP<2022>
9.6* Staphylococcus aureus n.d./10g Ph.Eur.2.6.13
9.7* Pseudomonas aeruginosa n.d./10g
Remark: 1.*perform the tests once half a year.

2. #perform the tests once a month.

Compendial requirements
The all-rac-α-Tocopheryl Acetate contained in this product meets all requirements of the relevant
monographs of FCC, USP and Ph. Eur. when tested according to these compendia.

Storage and Stability


The product may be stored for 36 months from the date of manufacture in the unopened original
container and at room temperature.

It should be protected from light, heat, oxygen and moisture. Keep the container tightly closed.
Once opened, use contents quickly.

Uses
Suitable for manufacturing low-content tablets and hard-shell capsules.

Safety
This product is safe for the intended use. Avoid ingestion, inhalation of dust or direct contact by
applying suitable protective measures and personal hygiene.

See Safety Data Sheet for full safety information.

Country of origin
China

Zhejiang Medicine Co.,Ltd. Xinchang Pharmaceutical Factory Product code: 4101152


Tel.: +86-575-86126668 Page 2 of 3 Date: 04-26-2022
Fax: +86-575-86131771 Version No.: 010.4
all-rac-α-Tocopheryl Acetate Powder 50% SF
EA 50% SF

Legal notice
The information given in this publication is based on our current knowledge and experience, and
may be used at your discretion and risk. It does not relieve you from carrying out your own
precautions and tests. We do not assume any liability in connection with your product or its use.
You must comply with all applicable laws and regulations, and observe all third party rights.

Zhejiang Medicine Co.,Ltd. Xinchang Pharmaceutical Factory Product code: 4101152


Tel.: +86-575-86126668 Page 3 of 3 Date: 04-26-2022
Fax: +86-575-86131771 Version No.: 010.4

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