Product Name | Vitamin E Oil | |
Shelf Life | 3 years | |
Item | Specification | Result |
Description | Clear, colourless slightly greenish-yellow, viscous, oily liquid, EP/USP/FCC | Clear, slightly greenish-yellow, Viscous, oily liquid |
Identification | ||
A Optical rotation | -0.01° to +0.01°, EP | 0.00° |
B IR | To conform, EP/USP/FCC | conform |
C Color reaction | To conform, USP/FCC | conform |
D Retention time, GC | To conform, USP/FCC | conform |
Related Substances | ||
Impurity A | ≤5.0%, EP | <0.1% |
Impurity B | ≤1.5%, EP | 0.44% |
Impurity C | ≤0.5%, EP | <0.1% |
Impurity D and E | ≤1.0%, EP | <0.1% |
Any other impurity | ≤0.25%, EP | <0.1% |
Total impurities | ≤2.5%, EP | 0.44% |
Acidity | ≤1.0ml, USP/FCC | 0.05mL |
Residual Solvents (Isobutyl acetate) | ≤0.5%, In-house | <0.01% |
Heavy metals (Pb) | ≤2mg/kg,FCC | <0.05mg/kg(BLD) |
Arsenic | ≤1mg/kg,In-house | <1mg/kg |
Copper | ≤25mg/kg,In-house | <0.5m/kg(BLD) |
Zinc | ≤25mg/kg,In-house | <0.5m/kg(BLD) |
Assay | 96.5% to 102.0%, EP96.0% to 102.0%, USP/FCC | 99.0%, EP99.0%, USP/FCC |
Microbiological tests | ||
Total aerobic microbial count | ≤1000cfu/g,EP/USP | Certified |
Total yeasts and moulds count | ≤100cfu/g,EP/USP | Certified |
Escherichia coli | n.d./g,EP/USP | Certified |
Salmonella | n.d./g,EP/USP | Certified |
Pseudomonas aeruginosa | n.d./g,EP/USP | Certified |
Staphyloscoccus aureus | n.d./g,EP/USP | Certified |
Bile-Tolerant Gram-Negative Bacteria | n.d./g,EP/USP | Certified |
Conclusion: Conform to EP/USP/FCC |
Vitamin E Oil
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