Items |
Standard |
Appearance |
Faintly yellowish to light yellow crystals. |
Solubility |
Sparingly soluble in water; slightly soluble in acetic acid and in methanol; very slightly soluble in dehydrated alcohol; practically insoluble in acetone, in acetonitrile, in ethylacetate, in hexane, and in methylene chloride. |
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 |
Residue on ignition |
NMT 0.1% |
Fluoroquinolonic acid (263nm) |
NMT 0.2% |
Ciprofloxacin ethylenediamine Analog (278nm) |
NMT 0.2% |
Any other Individual impurity (278nm) |
NMT 0.2% |
Total impurities (278nm) |
NMT 0.5% |
pH |
3.0 to 4.5 |
Water |
4.7% to 6.7% |
Ethanol |
NMT 4000ppm |