| Product Name | Cefradine | |
| Shelf Life | 2 years | |
| Tests | BP2012 Specifications | Results |
| 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 |
| Identification | IR spectrum should match with that of standard | Conform |
| Clarity of solution | Solution S is not more opalescent than reference suspension II | Conform |
| Absorbance at 450nm | Not more than 0.6 | 0.3 |
| pH | Between 3.0 and 6.0 | 4.7 |
| Specific optical rotation | Between +80.0°and +90.0°(anhydrous substance) | +85° |
| 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% |
| N,N-Dimethylaniline | Maximum 20 ppm | Not used in process |
| Water | Maximum 6.0%，determined on 0.300 g. | 4.3% |
| Sulphated ash | Maximum 0.2% | ＜0.1% |
| Assay | ||
| cefradine | Minimum 90.0% | 96.8% |
| cefalexin | Maximum 5.0% | 1.5% |
| 4′,5′-dihydrocefradine | Maximum 2.0 % | 1.0% |
| Sum of cefradine, cefalexin and 4′,5′-dihydrocefradine | Minimum 96.0%.and maximum 102.0%(anhydrous substance) | 99.3% |