CHARACTERS

Light yellowish-white to yellow-white crystals or crystalline powder

Light yellow-white crystalline powder

IDENTIFICATION

IR

The spectrum obtained from sample consists with that obtained from Levofloxacin RS

Complies

HPLC

The reaction time of major peak of the Sample solution corresponds to that the Stanard solution,as obtained in the Assay

Complies

Assay(on the anhydrous basis)

98.5%~102.0% of C18H20FN3O4

98.8%

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%

0.03%

Diamine derivative

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%

0.07%

Total impurities(except the D-isomer)

Not more than 0.5%

0.25%

Optical rotation(at 20°C)

-92°~ -106°

-98.3°

Water

2.1%~2.7%

2.7%

Residue solvents

Chloroform

Not more than 60ppm

40ppm

Ethanol

Not more than 1000ppm

464ppm

DMSO

Not more than 1000ppm

Not found

CONCLUSION

The result conform with the specification