| Analytical Items | Specifications | Analytical Results |
| characteristic | white or light yellow crystalline power | Complies |
|
Identification
(a) IR (b) TLC |
IR spectrum of sample conforms that of reference standard,The intensity and RF value of the principal band obtained from the test solution corresponds that obtained from the Standard solution | Complies |
| (c) Reation of Chloride | A solution of II responds to tests for Chloide | Complies |
| PH | 3.0~4.5 | 3.4 |
| Sulfate | ≤0.04% | <0.04% |
| Water | 4.7~6.7% | 0.062 |
| Residue onignition | ≤0.1% | 0.0004 |
| Heavy metals | ≤20ppm | <20ppm |
| Fluoroquinolonic acid | ≤0.2% | Complies |
| Chromatographic purity | ||
| Ciprofloxacin ethylenedianmine analog | ≤0.2% | 0.0017 |
| Any other impurity | ≤0.2% | 0.001 |
| Total imprities | ≤0.5% | 0.0041 |
| Residual solvents | 530ppm | |
| Ethanol | ≤4000ppm | Not found |
| Isoamyl alcohol | ≤4000pm | |
| Assay(on anhydrous basis) | 98.0%~102.0% of C17H18FN3O3HCL | 0.998 |