Levofloxacin hydrochloride

Assay (on the anhydrous basis)

98.5%~102.0% of C18H20FN3O4

99.30%

Impurities

Inorganic impurities

Residue on ignition

Not more than 0.2%

0.04%

Heavy metals

Not more than 10ppm

Less than 10ppm

Organic impurities

N-Desmethyl levofloxacin

Not more than 0.3%

0.04%

Diamine derivatice

Not more than 0.3%

0.01%

Levofloxacin N-oxide

Not more than 0.3%

Not found

9-Desfluoro levofloxacin

Not more than 0.3%

Not found

D-Isomer

Not more than 0.8%

0.20%

Any unknown impurity

Not more than 0.1%

0.09%

Total impurities (except the D-isomer)

Not more than 0.5%

0.30%

Optical rotation (at 20°C)

-92°~-106°

-104.2°

Water

2.1%~2.7%

2.40%

Residual solvents

Chloroform

Not more than 60ppm

32ppm

Ethanol

Not more than 1000ppm

289ppm

DMSO

Not more than 1000ppm

Not found

Conclusion

The results conform to USP35