Form
Powder
Appearance
White crystalline powder
Source
Synthetic
Impurity Profile
Impurity A| (RS)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid (FPA) ; Ofloxacin Difluoro Carboxylic Acid|82419-35-0|C13H9F2NO4|281.21| Impurity B| (RS)-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-2,3-dihydro-7H-pyrido-[1,2,3-de]-1,4-benzoxazin-7-one|||| Impurity E| (RS)-9-Fluoro-3-methyl-7-oxo-10-(piperazin-1-yl)-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid; N-Desmethyl Ofloxacin HCl|82419-52-1|C17H18FN3O4|347.34| Impurity F| 4-[(RS)-6-Carboxy-9-fluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-10-yl]-1-methylpiperazine 1-Oxide Hydrochloride (Ofloxacin N-Oxide Acetate Salt)|104721-52-0|C20H24FN3O7|437.42| | Ofloxacin R-Isomer; (+)-(R)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid ;(R)-(+)-Ofloxacin ;D-Ofloxacin ; Levofloxacin R-Isome|100986-86-5|C18H20FN3O4|361.37|
Melting Point
250-257°C
Optical Rotation
-1° to +1°
Assay
(On Dried Basis): 98.5-101.5%
Loss on Drying
≤0.2%
