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93107-08-5 Ciprofloxacin Hci C17H18FN3O3·HCl
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Function & Application
This product is one of the outstanding representatives of quinolone antibacterial drugs. It was successfully developed by Bayer Pharmaceuticals in Germany in 1983. The first generation of quinolone antibacterial drugs is represented by nalidixic acid, and the second generation is represented by pipemidic acid. The third generation is represented by norfloxacin. Ciprofloxacin has a broad antibacterial spectrum and strong antibacterial activity. It is effective against both Gram-positive and Gram-negative bacteria, as well as Pseudomonas aeruginosa, with few adverse reactions.
?PRODUCT NAME: | CIPROFLOXACIN HCL | |
Shelf Life | 3 years | |
SPECIFICATION: | USP 38 | |
Items | Specification | Results |
Appearance | Faintly yellowish to light yellow crystals. | Faintly yellowish crstals |
IDENTIFICATION | ||
A. IR | IR spectrum of sample conforms to that of reference standard. | Complies |
B. HPLC | The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. | Complies |
C. Reaction of chlorides | A solution of it responds to the tests for Chloride | Complies |
ASSAY(on anhydrous basis) | 98.0% ~ 102.0% of C17H18FN3O3•HCl | 100.5% |
Impurities | ||
Inorganic Impurities | ||
Residue on ignition | Not more than 0.1% | 0.01% |
Chloride and Sulfate | ||
Sulfate | Not more than 0.04% | Less than 0.04% |
Heavy metals | Not more than 0.002% | Less than 0.002% |
Organic Impurities | ||
Fluoroquinolonic acid (Method 1) | Not more than 0.2% | Less than 0.2% |
Ciprofloxacin ethylenediamine analog (Method 2) | Not more than 0.2% | 0.09% |
Any other Individual impurity (Method 2) | Not more than 0.2% |
0.08%(RRT:0.4) 0.05%(RRT:0.8) 0.06%(RRT:2.2) |
Total impurities (Method 2) | Not more than 0.5% | 0.41% |
pH | 3.0 ~ 4.5 | 3.9% |
Water | 4.7% ~ 6.7% | 5.9% |
Residual solvents | ||
Ethanol | Not more than 4000ppm | 54ppm |
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