Specification:
Items Standard
Appearance Faintly yellowish to light yellow crystals.
Solubility Sparingly soluble in water; slightly soluble in acetic acid; very slightly soluble in dehydrated alcohol; practically insoluble in aceton, in ethylacetate.
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 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%
Ethan NMT 4000ppm
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