China Sell Pharmaceutical Raw Powder CAS 38821-53-3 Cefradine
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.
| 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. |
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