TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | Yellowish crystalline powder | Conforms |
Identification | Meet the requirement | Conforms |
Melting point | 570℃~610℃ | 596℃ |
Specific rotation | -58°~-66° | -64° |
Single impurity | ≤0.20% | 0.12% |
Total impurities | ≤2.0% | 0.68% |
Cefdinir polymer | ≤0.5% | 0.005% |
Water | ≤2.0% | 0.76% |
Burning residue | ≤0.2% | 0.10% |
PH | 2.5~4.5 | 3.5 |
Assay | ≥97.0% | 99.50% |
Conclusion: The Product Conforms to CP/USP. |