|
Test item |
Specifications |
Results |
|
Characters |
Dark red crystals or crystalline red powder |
Complies |
|
Identification A(UV) |
Absorption at 278±1nm, 361±1nmand |
Complies |
|
A361/A278 nm 1.70-1.90 |
1.81 |
|
|
A361/A550 nm 3.15-3.40 |
3.32 |
|
|
Identification B(Chemistry) |
Positive |
Positive |
|
Identification C(HPLC) |
The retention time of the major peak of the Complies sample solution corresponds to that of the standard solution |
Complies |
|
Loss on drying |
≤12.0% |
5.8% |
|
Assay(on dry basis) (UV) |
96.0～102.0% |
99.2% |
|
Total impurities |
≤3.0% |
1.5% |
|
7β,8β-Lactocyanocobalamin |
≤1.0% |
0.07% |
|
50-Carboxycyanocobalamin |
≤0.5% |
ND |
|
34-Methyleyanocobalamin |
≤2.0% |
0.8% |
|
32-Carboxycyanocobalamin |
≤1.0% |
ND |
|
8-Epi-Cyanocobalmin |
≤1.0% |
0.05% |
|
Any other unidentified impurity |
≤0.5% |
0.16% |
|
Residual solvent(GC) Acetone |
≤0.5% |
0.001% |
|
Total plate count (Plate culture) |
≤1000cfu/g |
<10cfu/g |
|
Conclusion |
This product complies with the specifications of USP 2024. |
|
