|
Items |
Specification |
Results |
|
Characters |
Dark red ,crystalline powder or dark red crystals |
Complies |
|
Identification |
A: A361/A278nm:1.70-1.90
A361/A550nm :3.15-3.40 |
1.87
3.24 |
|
B:meets USP requirements |
Complies |
|
C:HPLC:the retention time of the major peak of the sample solution corresponds to that of the standard solution |
Complies |
|
Loss on drying |
≤10.0% |
1.21% |
|
Assay |
97.0-102.0% |
98.87% |
|
Related substances |
Total impurities ≤3.0% |
1.2% |
|
7β,8β-Lactocyanocobalamin≤1.0% |
0.70% |
|
32-carboxycyanocobalamin≤1.0% |
＜0.1% |
|
8-Epi-cyanocobalamin≤1.0% |
0.31% |
|
Any other impurity≤0.5% |
＜0.5% |
|
Resiudal solvent |
Acetone ≤0.5% |
0.02% |
|
Total plate count |
≤800cfu/g |
10cfu/g |
|
Yeasts and molds |
≤80cfu/g |
＜10cfu/g |
|
E.coli |
Negative |
Complies |
