CAS number： 93107-08-5
Molecular formula： C17H18FN3O3·HCl
molecular weight： 367.8
Chemical structure：
| 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 |
