Ciprofloxacin Base(86483-48-9)
Product Description
● Ciprofloxacin base is a fluoroquinolone with the same antibacterial spectrum as norfloxacin, and its antibacterial activity is the strongest among the widely used fluoroquinolones. In addition to its high antibacterial activity against gram-negative bacilli, it also has good antibacterial effect on Staphylococcus spp. and is slightly less effective than Staphylococcus spp. against pneumococcus and streptococcus spp.
● Ciprofloxacin base is used for the treatment of respiratory tract infections, urinary tract infections, intestinal tract infections, infections of all systems of the biliary tract, intra-abdominal infections, infections of gynecological diseases, bone and joint infections and serious infections of the whole body.
| Tests | Acceptance Criteria | Results | |
| Characters | Almost white or pale yellow crystalline powder | Pale yellow crystalline powder | |
| Identification | IR : Conforms to the spectrum of Ciprofloxacin RS. | Conforms | |
| HPLC:The retention time of the major peak of the Sample solution corresponds to that of the Standard solution , as obtained in the Assay. | |||
| Clarity of solution | Clear to slightly opalescent. (0.25g/10ml 0.1N Hydrochloric acid) | Conforms | |
| Loss on drying | ≤1.0% (Dry in vacuum at 120°C) | 0.29% | |
| Residue on ignition | ≤0.1% | 0.02% | |
| Heavy metals | ≤20ppm | <20ppm | |
| Chromatographic purity | Ciprofloxacin ethylenedianiine analog | ≤0.2% | 0.07% |
| Fluoroquinolonicacid | ≤0.2% | 0.02% | |
| Any other single impurity | ≤0.2% | 0.06% | |
| Total impurities | ≤0.5% | 0.19% | |
| (HPLC) Assay | C17H18FN3O3 98.0%~ 102.0% (On the dried basis) | 100.7% | |
| Conclusion: Conforms to USP41 specification for Ciprofloxacin | |||
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