Ofloxacin

ITEMS

STANDARD

RESULTS

Identification

A: IR test

B: UV test

Conforms

Description

Yellowish white crystalline powder

Conforms

Specific rotation

-1⁰ ~ +1⁰

-0.50⁰

Loss on drying

≤0.2%

0.15%

Purity Test (HPLC)

A: Individual impurity

B: 9-desfluoro ofloxacin

C: total impurity

≤0.3%

≤0.2%

≤0.5%

0.20%

0.12%

0.30%

Residue on ignition

≤0.1%

0.06%

Heavy Metals

≤0.001%

<0.001%

Arsenic

≤1ug/g

Conforms

Residual Solvents

A: Methanol

B: Ethanol

≤0.005%

≤0.05%

<0.005%

<0.05%

Assay

≥98.5%

99.22%