Product Description

Vitamin A Palmitate 1.0M (Toc.) is fat-like, light yellow solid or yellow oily liquid and soluble in fats and oil. the addition of an antioxidant as all-rac-α-tocopherol (Toc.E307) will stabilize the product. Storage below 15°C will enhance shelf life but may cause crystallization. Gentle warming less than 40℃ and thorough mixing before use will melt and homogenize the product.

Product Identification

SynonymRetinol palmitate

CAS No.79-81-2

EINECS No.201-228-5

INCI nameRetinyl palmitate Chemical Formula:                                  C₃₆H₆₀O₂

Molecular Weight:                                     524.87

Specifications

Description	A light yellow solid or yellow oily Liquid
Identification
Hin-Layer Chromatographic	Conform
Related Substance Ratios
A300/A326	≤0.60
A350/A326	≤0.54
A370/A326	≤0.14
Assay
EXpressed as International units	≥1000000IU/g
Expressed as equivalent amount of retinol	≥300 mg/g
Acid value	≤2.0mg/g
Peroxide value	≤10.0meq/kg
Chroma	≤3.0
Retinol	≤1.0%
All Trans-isomer Content	≥95.0%
* Residue Solvent	Conform to ICH
*Heavy Metals	≤5 mg/kg
*Arsenic	≤1 mg/kg
*Lead	≤2 mg/kg
*Microbiological tests
Total aerobic Microbial count	≤1000 CFU/g
Total mold & yeast count	≤100 CFU/g
Coliforms	≤3.0 MPN/g
Salmonella	N.d./25g
E.Coli	≤10 CFU/g
Staphylococcus Aureus	N.d./25g

 

Remark: the item marked with "*" ensured by quality assurance measures and therefore tested randomly only.

Compendial requirements

the Vitamin A palmitate meets all requirements of the relevant monographs of USP and EP when tested according to these compendia.

Storage and Stability

the product may be stored for 24 months from the date of manufacture in the unopened original container and at temperature below 15°C. Lower storage temperature is more beneficial to stability of vitamin A palmitate.

It should be protected from light, heat (especially at temperature higher than 40°C), oxygen and moisture. Keep the container tightly closed. Once opened, use contents quickly.

Uses

It is mainly for fortification of oils and fats (e.g. Margarine) and dairy products in food industry and for liquid pharmaceutical preparations such as soft-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 Material Safety Data Sheet for full safety information.

Country of origin

China.