Test

Specification

Results

Characteristics

White or light yellow crystallinepowder

Complies

Identification

(A)IR

( B)TLC

(C ) Reaction ofchloride

IR spectrum ofsample conforms to that of reference standard.

The intensity and RFvalue of the principal band obtained from the testsolution.corresponds to that obtained from the standardsolution

A solution of IIresponds to the tests for Chloride.

Complies

Complies

Complies

PH

3.0 ~4.5

3.5

Sulfate

≤0.04%

<0.04%

Water

4.7% ~ 6.7%

5.0%

Residue on ignition

≤0.1%

0.05%

Heavy metals

≤20ppm

<20ppm

Fluoroquinolonic acid

≤0.2%

Complies

Chromatographicpurity                                                                                                                       

Ciprofloxacinethylenediamine analog

Any otherimpurity

Totalimprities

≤0.2%

≤0.2%

≤0.5%

0.11%

0.15%

0.42%

Residual solvents

Ethanol

Isoamylalcohol

≤5000ppm

≤4000ppm

572ppm

Notfound

Assay ( on anhydrous basis)

98.0%~102.0% ofC17H18FN3O3.HCL

99.6%

Conclusion

Complies with USP32