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% |