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10 Kilogram |
Negotiable |
Cyanocobalamin VB12 Vitamins
we have GMP USP/EP standard
Cyanocobalamin (vitamin B12)
Characteristics |
Dark-red crystalline powder or crystals |
|
Solubility |
Sparingly soluble in water and ethanol(96%),practically insoluble in acetone. |
|
Identification |
Ratio of optical density A361/A550nm: 3.15~3.40 A361/A278nm: 1.7~1.88 TLC: Conforms Chemical:Positive HPLC:the retention time of major peak of the sample solution corresponds to that of the standard solution |
|
Pseudo cyanocobalamin |
USP(separator) |
|
Related substances |
||
Total impurities |
≤3.0% |
|
Single impurity |
7β,8β-lactocyanocobalamin≤1.0% 50-carboxycyanocobalamin≤0.5% 34-methylcyanocobalamin≤2.0% 32-carboxycyanocobalamin≤1.0% 8-epi-cyanocobalamin≤1.0% Any other unidentified impurity≤0.5% |
|
Loss on drying |
≤12.0% |
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Assay on dried basis |
96.0%~102.0% |
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Residual solvents |
Acetone: ≤ 1000ppm Ethanol: ≤ 1000ppm |
|
Total plate count(CFU/g) |
≤ 100 |
|
Yeast and Mould(CFU/g) |
≤10 |
|
Enterobacteriae |
Negative |
|
Staphylococcus aureus |
Negative |
|
Pseudomonas aeruginosa |
Negative |
|
Endotoxin |
<0.35EU/µg |
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