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CAS number： 93107-08-5
Molecular formula：
molecular weight：
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 |