Appearance

White or off-white crystalline powder

IDENTIFICATION

(1)Chemical reaction

Positive

(2)Chemical reaction

A reddish brown color is produced

(3)HPLC

The retention time of the majoy peak of the sample solution correspons to that of the standard solution,as obtained in the assay.

(4)IR

The spectrum of sample conforms to that of the reference spectrum.

(5)Reaction of chlorides

A solution of it responds to the test for Chiorides.

TESTS

pH

3.5~4.5

Appearance of solution

The solution time of the majoy peak of the sample solution corresponds to that of the standard solution,as obtained in the assay.

Fluoroquinolonic acid

Not more than 0.2%

Related substances

Ciprofloxacin

Not more than 0.5%

Unspecified impunity

Not more than 0.3%

Total impurity

Not more than 0.7%

Loss on drying

Not more than 1.0%

Residue on ignition

Not more than 0.2%

Heavy metals

Not more than 0.002%

Assay(on dried basis)

C19H22FN3O3

89.5%~92.0%

C19H22FN3O3 ·HCL

Not less than 98.5%