| Items | Specifications |
| CHARACTERS | |
| Appearance | Faintly yellowish to light yellow crystals. |
| IDENTIFICATION | |
| A.IR | IR spectrum of sample conforms to that of reference standard. |
| 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. |
| C.Reaction of chlorides | A solution of it responds to the tests for Chloride |
| ASSAY (on anhydrous basis) | 98.0%~102.0% of C17H18FN3O3·HCL |
| Impurities | |
| Inorganic Impurities | |
| Residue on ignition | Not more than 0.1% |
| Organic Impurities | |
| Fluoroquinolonic acid (263nm) | Not more than 0.2% |
| Any other Individual impurity (278nm) | Not more than 0.2% |
| Total impurities (278nm) | Not more than 0.5% |
| PH | 3.0~4.5 |
| Water | 4.7%~6.7% |
| Residual solvents | |
| Ethanol | Not more than 4000ppm |
| Bacterial endotoxin | Less than 0.20EU/mg |
| Microbial limit | TAMC not more than 100cfu/g |
| TAMC not more than 10cfu/g |
Complaint
