TESTING ITEM

SPECIFICATION

RESULT

Characters

Appearance

White crystalline powder

White crystalline powder

Identification

Meet the requirements

Meet the requirements

Tests

Clarity of solution

Meets the requirements

Meets the requirements

Loss on drying

≤1.0%

Not more than 1.0%

0.2%

Residue on ignition

≤0.1%

Not more than 0.1%

0.1%

Chloride

≤0.02%

Not more than 0.02%

<0.02%

Sulfate

≤0.04%

Not more than 0.04%

<0.04%

Heavy metals

≤0.002%

Not more than 0.002%

<0.002%

Fluoroquinolonic acid

Meets the requirements

Meets the requirements

Impurities

≤0.5%

Not more than 0.5%

0.21%

Ciprofloxacin ethylenediamine analog

≤0.2%

Not more than 0.2%

0.07%

Any other individual impurity

≤0.2%

Not more than 0.2%

0.06%

Assay (on the dried basis)

98.0%~102.0%

Between 98.0% and 102.0%

100%

Conclusion: Meet the requirement of USP32