Items

Standard

Result

Appearance

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 retention time of the major peak of the sample solution corresponds to that of the standard solution , as obtained in the assay

complies

Assay (on the anhydrous basis)

98%-102% of C18H20FN3O4

99.1%

Impurities

Inorganic impurities

Residue on ignition

NMT 0.2%

0.04%

Organic impurities

Procedure 1(by HPLC)

N-desmethyl levofloxacin

NMT 0.3%

0.02%