TEST

SPECIFICATION

RESULT

Description

White to pale yellow,hydroscpion, photosensitive,

crystalline powder

Complies

Identification

IR

Complies

Appreance of solution

Complies

Complies

Related Substances

Impurity E

max.0.1%

0.01%

Methyl-Norfloxacin

max.0.15%

0.08%

Unspecicifed Impurities

max.0.1%

0.04%

Total Impurities

max.0.5%

0.2%

Loss on drying

max.1.0%

0.3%

Residue on ignition

max.0.1%

0.05%

Heavy metals

max.15ppm

10ppm

Purity

chromatographic

The sum of all impurities’peaks  is not more than 0.5%

Complies

Assay

99.0%-101.0%

99.8%

Residual Solvents Ethanol

max.5000ppm

Not detected