Ciprofloxacin Hydrochloride (Hcl/Base) CAS# 93107-08-5 USP Standard
| Item | Specification | Results | |
| Appearance | Faintly yellowish to light yellow crystals | Faintly yellowish crystals | |
| Identification | ⑴ IR: IR Spectrum of sample conforms to that of the reference standard | Complies | |
| ⑵ HPLC:The retention of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay | Complies | ||
| ⑶ Reaction of chloride: A solution of it responds to the test for chloride | Complies | ||
| Assay (on anhydrous basis) | 98.0-102.0% of C17H18FN3O3.HCL | 100.9% | |
| Residal on ignition | ≤ 0.1% | 0.02% | |
| Sulfate | ≤ 0.04% | Less than 0.04% | |
| Heavy metals | ≤ 0.002% | Less than 0.002% | |
| Organic impurities | Fluoroquinolonic acid (Method 1)≤0.2% | Less than 0.2% | |
| Ciprofloxacin ethylenediamine analog (Method 2)≤0.2% | 0.19% | ||
| Individual impurity (Method 2)≤0.2% | 0.07% (RRT:0.4) | ||
| Total impurities (Method 2)≤0.5% | 0.36% | ||
| PH | 3.0-4.5 | 3.5 | |
| Water | 4.7-6.7% | 6.1% | |
| Residual solvents | Ethanol≤4000ppm | 35ppm | |
