Form

Powder

Appearance

Light Yellow Crystalline Powder

Source

Synthetic

Impurity Profile

Impurity A| (-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid; N-Desmethyl Levofloxacin|117707-40-1|C₁₇H₁₈FN₃O₄|347.34| Impurity B| 8,9-Difluoro-3-methyl-6-oxo-2,3-dihydro-6H-1-oxa-3a-aza-phenalene-5-carboxylic acid; Levofloxacin Difluoro Carboxylic Acid|100986-89-8|C₁₃H₉F₂NO₄|281.21| Impurity C| Ethyl (S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylate ; Levofloxacin Ethyl Ester|177472-30-9|C₂₀H₂₄FN₃O₄|389.42| Impurity D||||| Impurity UN1| LEVOFLOXACIN N-OXIDE ; (-)-(S)-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 N-oxide||C₁₈H₂₀FN₃O₅|377.37| Levofloxacin 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; D-Levofloxacin|100986-86-5|C₁₈H₂₀FN₃O₄|361.37| Levofloxacin Desethylene Impurity| N,N＊-Desethylene Levofloxacin Hydrochloride; (-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-[(2-methylamino)ethylamino]-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine||C₁₆H₁₉ClFN₃O₄|371.79| Levofloxacin Descarboxy Impurity| (-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine|178964-53-9|C₁₇H₂₀FN₃O₂|317.36| Levofloxacin Desethylene Diformyl Impurity| Desethylene Diformyl Levofloxacin; N,N＊-Desethylene-N,N＊-diformyl Levofloxacin; (S)-9-Fluoro-10-[formyl[2-(formylmethylamino)ethyl]amino]-2,3-dihydro-3-methyl-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid|151377-74-1|C₁₈H₁₈FN₃O₆|391.35| Levofloxacin Desfluoro Impurity| (-)-(S)-2,3-Dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid|117620-85-6|C₁₈H₂₁N₃O₄|343.38|

Melting Point

218-227 °C

Optical Rotation

-95° to -103°

Assay

≥98.5%

Loss on Drying

≤3.0%