Cephradine C16H19N3O4S 38821-53-3
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Cefradine is the first-generation semi-synthetic cephalosporin. It is acid-resistant and can be taken orally. It has good absorption and high blood concentration. It is characterized by resistance to β-lactamase, resistant to drug-resistant Staphylococcus aureus and other broad-spectrum antibiotics. Bacillus has a rapid and reliable bactericidal effect.
Cefradine is clinically mainly used for infections of the respiratory tract, urinary tract, skin and soft tissues, such as bronchitis, pneumonia, pyelonephritis, cystitis, ear, nose, and throat infections, enteritis and dysentery.
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% |
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