Superiority:
Appearance
Almost white or pale yellow crystalline powder
Identification IR: Conforms to standard USP
HPLC: Comforms to standard
Assay,HPLC, on dry base C17H18FN3O3 98.0-102.0%
Impurities Ciprofloxacin ethylenediamine analog:0.2% max
Any other single impurity:0.2% max
Total impurities: 0.5% max
Clarity of solution Clear to slightly opalescent
(0.25g/10ml 0.1N Hydrochloric acid)
Loss on drying 1.0% max
Residue on ignition 0.1% max
Chloride 0.02% max
Sulfate 0.04% max
Heavy metals 20ppm max
Fluoroquinolonic acid 0.2% max
Details:
Appearance
Almost white or pale yellow crystalline powder
Identification IR: Conforms to standard USP
HPLC: Comforms to standard
Assay,HPLC, on dry base C17H18FN3O3 98.0-102.0%
Impurities Ciprofloxacin ethylenediamine analog:0.2% max
Any other single impurity:0.2% max
Total impurities: 0.5% max
Clarity of solution Clear to slightly opalescent
(0.25g/10ml 0.1N Hydrochloric acid)
Loss on drying 1.0% max
Residue on ignition 0.1% max
Chloride 0.02% max
Sulfate 0.04% max
Heavy metals 20ppm max
Fluoroquinolonic acid 0.2% max