dl-α-Tocopheryl Acetate

EA 98

Data Sheet

Product Description

DL-alpha-Tocopheryl Acetate is a clear, colorless, slightly greenish-yellow viscous oily liquid.

Product Identification

Synonym Tocopheryl acetate

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

CH3CO

Chemical Formula: C 31 H 52 O 3 Molecular Weight: 472.75

Specifications

Items Specifications Test Method

Clear, colorless slightly greenish-yellow,
1 Description Visual
viscous, oily liquid. Ph.Eur /USP/FCC
2 Identification
A optical rotation -0.01°~ +0.01°, Ph.Eur Ph.Eur 2.2.7
B IR To conform, Ph.Eur /USP/FCC Ph.Eur 2.2.24
B Color reaction To conform, USP/FCC USP
C Retention time, GC To conform, USP/FCC GC
3 Related Substances
Impurity A ≤ 0.5%, Ph.Eur
Impurity B ≤ 1.5%, Ph.Eur
Impurity C ≤ 0.5%, Ph.Eur Ph.Eur 2.2.28
Impurities D and E ≤ 1.0%, Ph.Eur
Any other impurity ≤ 0.25%, Ph.Eur
Total impurities ≤ 2.5%, Ph.Eur
4 Acidity ≤ 1.0ml, USP/FCC USP/FCC
Ph.Eur 2.4.24
5 Residual Solvents To conform
USP <467>
6 Heavy metals
Pb ≤ 2mg/kg, FCC AA

Zhejiang Medicine Co.,Ltd. Xinchang Pharmaceutical Factory Sequence No.: 4100102

Tel.: +86-575-86126668 Page 1 of 3 Date: 07-31-2022
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dl-α-Tocopheryl Acetate
EA 98

Items Specifications Test Method

7 Arsenic ≤ 1mg/kg (in-house) ChP 0822

8 Copper ≤ 25mg/kg (in-house)

ICP-MS
9 Zinc ≤ 25mg/kg (in-house)

10 Pd ≤ 5mg/kg (in-house) AA
96.5%~102.0% Ph.Eur
11 Assay Ph.Eur 2.2.28
96.0%~102.0% USP/FCC
12 *Microbiological tests
Total aerobic microbial count ≤1000cfu/g, Ph.Eur /USP USP<61>
Total yeasts and moulds count ≤100cfu/g, Ph.Eur /USP Ph. Eur.2.6.12
Escherichia coli n.d./g, Ph.Eur /USP
Pseudomonas aeruginosa n.d./g, Ph.Eur /USP
USP<62>
Staphylococcus aureus n.d./g, Ph.Eur /USP
Ph. Eur.2.6.13
Enterobacteria n.d./g, Ph.Eur /USP
Salmonella n.d./10g, Ph.Eur /USP
Remark: *Conduct every tenth batch.

Compendial requirements
The dl-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
For fortification of margarine, oil and fat, nutrition products and baby food, also used in soft
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.

Zhejiang Medicine Co.,Ltd. Xinchang Pharmaceutical Factory Sequence No.: 4100102

Tel.: +86-575-86126668 Page 2 of 3 Date: 07-31-2022
Fax: +86-575-86131771 Version No.: 008.1
dl-α-Tocopheryl Acetate
EA 98

Country of origin
China

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 Sequence No.: 4100102

Tel.: +86-575-86126668 Page 3 of 3 Date: 07-31-2022
Fax: +86-575-86131771 Version No.: 008.1