Name | Vitamin B12 (Cyanocobalamin) | ||||||||
Test Item | Specification | ||||||||
Appearance | Dark red crystal or crystalline powder, with no smell and no taste; hygroscopicity. | ||||||||
Identification A | A361nm/A278nm:1.70-1.90 | ||||||||
A361nm/A550nm:3.15-3.40 | |||||||||
Identification B | The retention time of major peak of the sample should be consistent with the standard solution. | ||||||||
Identification C | Positive | ||||||||
Infrared Spectrum | Infrared spectrum of the sample should be consistent with the reforence map | ||||||||
Loss on drying | ≤12.0% | ||||||||
Assay | 96.0%~102.0% | ||||||||
7β、8β-lactocyanocobalamin | ≤1.0% | ||||||||
50-carboxyeyanocobalamin | ≤0.5% | ||||||||
34-methylcyanocobalamin | ≤2.0% | ||||||||
32-carboxyeyanocobalamin | ≤1.0% | ||||||||
8-Epi-cyanocobalamin | ≤1.0% | ||||||||
Any other unidentified | ≤0.5% | ||||||||
Total impurities | ≤3.0% | ||||||||
Total aerobic bacteria count | ≤1000cfu/g | ||||||||
Molds、Yeasts | ≤100cfu/g | ||||||||
E、coli | Negative | ||||||||
Residual solvents | Acetone≤0.5% |
Name | Methylcobalamin(Mecobalamin) |
Characters | Dark red crystals or crystalline powder. |
Identification | (1)UV : Compare the spectrum with the reference spectrum. Both spectra exhibit similar intensities of absorption at the same wavelengths. |
(2)Cobalt : Meets JP requirement | |
Clarity and color of solution | The solution is clear and red color |
Related substances | Each area of the peaks other than mecobalamin is not more than 0.5% of the peak area of mecobalamin |
The total area of the peaks other than mecobalamin is not more than 2.0% | |
Water | ≤11.5% |
Assay (Calculated on the anhydrous basis) | 98.5%-101.0% |
Acetone | ≤5000pm |
The total aerobic microbial count | ≤1000 cfu/g |