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TEST | SPECIFICATION | RESULT | |
Description | White to pale yellow,hydroscpion, photosensitive, crystalline powder | Complies | |
Identification | IR | Complies | |
Appreance of solution | Complies | Complies | |
Related Substances | Impurity E | max.0.1% | 0.01% |
Methyl-Norfloxacin | max.0.15% | 0.08% | |
Unspecicifed Impurities | max.0.1% | 0.04% | |
Total Impurities | max.0.5% | 0.2% | |
Loss on drying | max.1.0% | 0.3% | |
Residue on ignition | max.0.1% | 0.05% | |
Heavy metals | max.15ppm | 10ppm | |
Purity chromatographic | The sum of all impurities’peaks is not more than 0.5% | Complies | |
Assay | 99.0%-101.0% | 99.8% | |
Residual Solvents Ethanol | max.5000ppm |