Ofloxacin with high quality

Analysis Specification

Result

Description

White or yellow light crystalline powder

Conform

Identification

A:IR test

B:UV test

Conform

Specific rotation

-1°~ -3°

+0.27°

Residual Solvents

A: Methanol

B: Ethanol

≤0.005%

≤0.05%

<0.005%

<0.05%

Purity test(HPLC)

A: Individual impurity

B: 9-desfluoroofloxacin

C: Total impurity

≤0.3%

≤0.2%

≤0.5%

0.19%

0.08%

0.22%

Loss on drying(%)

≤0.2%

0.18%

Residue on ignition(%)

≤0.1%

<0.08%

Heavy metals

≤0.001%

<0.001%

Arsenic

≤1ug/g

Conform

Assay

≥98.5%

99.2%

Conclusion

Conformwith USP30, EP5, BP2002 and CP2005.