CAS number： 13422-55-4
Molecular formula： C63H91CoN13O14P
molecular weight： 1344.3823
Chemical structure：
| Product name: | Mecobalamin | ||
| Shelf life | Three years | ||
| Inspection Standard: | JP XVI and in house standard | ||
| Items | Specifications | Results | Test methods |
| Characters | Dark red crystals or crystalline powder | Complies | JP Monograph Visual method |
| Identification | (1) UV: Compare the spectrum with the reference spectrum, Both spectra exhibit similar intensities of absorption at the same wavelengths | Complies | JP Monograph |
| (2) Chemical: meets JP requirements | Complies | JP Monograph | |
Purity (1) Clarity and color of solution | solution is clear and red color | Complies | JP Monograph |
| (2) Related substances | Each area of the peaks other than mecobalamin is not larger than 0.5% of the peak area of mecobalamin | Complies | JP Monograph/JP <2.01> |
| The total area of the peaks other than mecobalamin is not larger than 2.0% | 0.69% | ||
| Water | ≤11.5% | 4.72% | JP Monograph/ JP <2.48> |
| Assay | ≥98.5% | 99.6% | JP Monograph |
| Residual solvent | Acetone ≤0.5% | 0.02% | in house/ ( GC) |
| Total plate count | ≤800 cfu/g | ＜10cfu/g | Ch.P.Appendix XI J |
| Yeasts and Molds | ≤80 cfu/g | ＜10cfu/g | |
| E.coli | Negative | Complies | |
| Conclusion : The product complies with the specification of JP XVI and in house standard | |||
