CAS number: 59-02-9
Molecular formula:
molecular weight:
Chemical structure:
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%, EP 96.0% to 102.0%, USP/FCC |
99.0%, EP 99.0%, 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 |