Characteristics

Faintly yellowish to light-yellow crystalline powder

Faintly yellowish crystalline powder

Identification

(A) IR

(B) TLC

(C) Reaction of chloride

Meet the requirements

Complies

PH

Between 3.0 and 4.5

3.6

Sulfate

Not more than 0.04%

Complies

Water

Between 4.7% and 6.7%

5.70%

Residue on ignition

Not more than 0.1%

0.05%

Heavy metals

Not more than 0.002%

<0.002%

Fluoroquinolonic acid

Not more than 0.2%

Complies

Chromatographic purity

Not more than 0.5%

0.32%

Ciprafloxacin ethylenediamine analog

Not more than 0.2%

0.10%

Any other individual impurity

Not more than 0.2%

0.07%

Ethanol

Isoamyl alcohol

Not more than 0.4%

Not more than 0.4%

<0.4%

<0.4%

Assay

Between 98.0% and 102.0%

99.2%

Conclusion

Complies with USP31