| Transport Package: | 25kg/Package |
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| Specification: | POWDER |
| Trademark: | TNN |
| Origin: | China (Mainland) |
| Samples: |
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| Customization: |
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| Tests | Acceptance Criteria | Results | ||
| Characters | Appearance | Faintly yellowish to light yellow crystalline powder | Faintly yellowish crystalline powder | |
| Solubility | Sparingly soluble in water; slightly soluble in acetic acid and methanol; very slightly soluble in dehydrated alcohol; practically insoluble in acetone, in acetonitrile, in ethylacetate, in hexane, and in methylene chloride. | / | ||
| Identification | (1)IR:Conforms to the spectrum of Ciprofloxacin Hydrochloride RS. (2)HPLC:The retention time of major peak of the Sample solution corresponds to that of the Standard solution,as obtained in the Assay. (3)Responds to the tests for chloride | Confroms | ||
| pH | 3.0 to 4.5(25mg/ml water) | 3.8 | ||
| Water | 4.7% ~6.7% | 6.3% | ||
| Residue on ignition | ≤0.1% | <0.01% | ||
| Heavy metals | ≤20ppm | <20ppm | ||
| Sulphates | ≤400ppm | <400ppm | ||
| (HPLC)Organic impurities | Ciprofloxacin ethylenediamine analog | ≤ 0.2% | 0.08% | |
| Fluoroquinolonic acid | ≤ 0.2% | 0.05% | ||
| Any other Individual impurity | ≤ 0.2% | 0.05% | ||
| The sum of all impurities | ≤ 0.5% | 0.13% | ||
| (HPLC)ASSAY | 98.0%~102.0% of C17H18FN3O3·HCL(On the anhydrous substance) | 100.0% | ||
| Residual solvents | Ethanol | ≤5000ppm | 173ppm | |
| Toluene | ≤890ppm | Not detected | ||
| Conclusion: | The product above complies with the standard of USP42. | |||
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