TESTING ITEMS | SPECIFICATIONS | RESULTS |
Characteristics | Almost white or pale yellow crystalline powder | Conforms |
Identification | Meet the requirements | Conforms |
Related substances | Ciprofloxacin Ethylenediamine ≤0.2% | 0.07% |
Any other single impurity ≤0.2% | 0.05% | |
Total impurities ≤0.5% | 0.17% | |
Loss on drying | ≤1.0% | 0.18% |
Residue on ignition | ≤0.1% | 0.03% |
Chloride | ≤0.02% | <0.02% |
Sulfate | ≤0.04% | <0.04% |
Heavy metals | ≤20ppm | <20ppm |
Assay | 98.0%~102.0% | 99.83% |
Conclusion: The Product Conforms to USP. |