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Item | Standard | Result | Test Method |
Appearance | Dark red crystal or crystalline powder, with no smell and no taste; hygroscopicity | Dark red crystal or crystalline powder, with no smell and no taste; hygroscopicity | Visual Method |
Identification A | A361nm/A278nm; 1.70-1.90 | 1.87 | UV |
A361nm/A550nm; 3.15-13.40 | 3.26 | ||
Identification B | The retention time of major peak of the sample should be consistent with the standard solution | Up to standard | HPLC |
Identification C | Positive | Up to standard | |
Infared Spectrum | infared spectrum of the sample should be consistent with the reference map | Up to standard | IR |
Loss on drying | ≤12.0% | 2.60% | USP<731> |
Assay | 96.0%-102.0% | 98.90% | UV |
7β,8β-lactocyanocobalamin | ≤1.0% | Not detected | HPLC |
50-carboxyeyanocobalamin | ≤0.5% | 0.04% | |
34-methylcyanocobalamin | ≤2.0% | 1.50% | |
32-carboxyeyanocobalamin | ≤1.0% | 0.08% | |
8-Epi-cyanocobalamin | ≤1.0% | Not detected | |
Any other unidentified | ≤0.5% | 0.10% | |
Total impurities | ≤3.0% | 1.80% | |
Total aerobic bacteria count | ≤1000cfu/g | 50cfu/g | USP<2021> |
Molds,Yeasts | ≤100cfu/g | 10cfu/g | USP<2021> |
E,coli | Negative | Not detected | USP<2022> |
Residual solvents | Acetone≤0.5% | Not detected | In house |
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