China Sell Pharmaceutical Raw Powder CAS 38821-53-3 Cefradine, Find details about China CAS 38821-53-3, Cefradine Powder from China Sell Pharmaceutical Raw Powder CAS 38821-53-3 Cefradine
Tests | BP2012 Specifications | Observations |
Appearance | White or slightly yellow powder.hygroscopic powder. | White powder, hygroscopic powder. |
Solubility | Slightly soluble in water,practically insoluble in ethanol 96 percent and in hexane. | Conform |
Indent cation | 1R spectrum should match with that of standard | Conform |
Appearance of solution | ||
Clarity of solution | Solution S is not more opalescent than referenee suspension 11 | Conform |
Absorbance al 450 nm | Not more than 0.6 | 0.3 |
pH | Between 3.0 and 6.0 | 4.9 |
Specific optical rotation | Between +80.0°and +90.0°(anhydrous substance) | +84° |
Related substances | ||
Impurity B: | Maximum0.25% | <0.25% |
impurities A, C. D. E, F, G | Maximum0.25% | <0.25% |
Any other impurity: | Maximum0.5% | <0.5% |
Total impurity: | Maximum2.0% | <2.0% |
MN-Dimethylani1ine | Maximum 20 ppm | Not used in process |
Water | Maximum 6.0%, determined on 0.300 g. | 4.1% |
Sulphated ash | Maximum 0.2% | 0.1% |
Assay | ||
cefradine | Minimum 90.0% | 96.5% |
cefalexi n | Maximum 5.0% | 1.5% |
4',5'-dihydrocefradine: | Maximum 2.0 % | 1.6% |
Sum of cefradine. cefalexin and 4',5'-dihydrocefradine | Minimum 96.0%.and maximum 102.0%(anhydrous substance) | 99.6% |
Tapped Density | 0.94g/ml | |
Remark: The product complies as per above BP2012 specifications. |