Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Customized |
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Pharmaceuticals:
1) Improving drug bioavailability
2) Emulsion vehicle
3) Functional ingredient in self-emulsifying formulations
4) Reducing drug sensitivity on skin or tissues
Food and beverages:
1) Liquid vitamin E or liquid multivitamin/mineral supplements
2) Other forms of vitamin E or multivitamin/mineral dietary supplements such as tablets, softgels, bars and others.
Personal Care and Cosmetics:
1) Cream, lotions and other products for topical application of vitamin E and other formulated actives.
2) Eye drops, nasal sprays, syrups and others primarily in formulating active compounds.
Description |
Clear, Colourless slightly greenish-yellow oily liquid |
Conform |
Identification |
|
|
Optical rotation |
-0.01°~+0.01°, Ph.Eur. |
0.00° |
IR |
Ph.Eur./USP/FCC |
Conform |
Color reactio |
USP/FCC |
Conform |
Related substances |
|
|
Impurity A |
≤0.5% |
<0.1% |
Impurity B |
≤1.5% |
0.56% |
Impurity C |
≤0.5% |
<0.1% |
Impurity D and E |
≤1.0% |
<0.1% |
Any other impurity |
≤0.25% |
0.11% |
Totoal impurity |
≤2.5% |
0.67% |
Acidity |
≤1.0ml |
0.06ml |
Residual solvents | To conform(In- house) | Conform |
Heavy metals | ||
Pb | ≤2mg/kg | <0.05mg/kg |
Arsenic | ≤1mg/kg(In-house) | <1mg/kg |
Copper | ≤25mg/kg | <2mg/kg |
Zine | ≤25mg/kg | <2mg/kg |
Palladium | ≤5ppm | <1ppm |
Assay | 96.0%-102.0% | 99.3% |
Microbial limit | ||
TAMC | ≤1000cfu/g | Certified |
TYMC | ≤100cfu/g | Certified |
Conclusion: Conforms to Ph. Eur./USP/FCC |