Varieties: | Antibiotic Medicine |
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Component: | Chemical Synthetic Drugs |
Type: | Other |
Pharmacodynamic Influential Factors: | Other |
Storage Method: | Prevent Exceeding Quality Guarantee Period |
Veterinary Reg. No.: | Other |
Customization: |
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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 |
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