CERTIFICATEOFANALYSIS Name:CYANOCOBALAMIN(B12)BatchNumber:C121109 BatchSize:65kgPackingSize:1kg/...
Items of analysis | Specification | Results | |
Appearance | Dark-red crystalline powder or crystals | Conforms | |
Identification Ratio of optical density A361/A550NM A361/A278NM TLC Chemical HPLC | 3.15-3.40 1.70-1.9 Conforms Positive The retention time of major peak of the sample solution corresponds to that of the standard solution. | 3.25 1.87 Conforms Positive Conrrespond | |
Related substances (HPLC) | 7-β,8β-lactocyanocobalamin | ≤1.0% | 0.2% |
50-carboxycyanocobalamin | ≤0.5% | Not detected | |
34-methylcyanocobalamin | ≤2.0% | 0.6% | |
32-carboxycyanocobalamin | ≤1.0% | Not detected | |
8-Epi-cyanocobalamin | ≤1.0% | Not detected | |
Any other unidentified inpurities | ≤0.5% | 0.2% | |
Total impurities | ≤3.0% | 1.6% | |
Loss on drying | ≤12.0 | 2.1% | |
Residual solvents | Ethanol≤5000ppm | 72ppm | |
Acetone≤5000ppm | 32ppm | ||
Assay(HPLC) | 96.0%~102.0%(Anhydrous substance) | 98.9% | |
Conclusion | Conform with the specifications. |
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