Form

Powder

Appearance

Creamcoloredpowder

Source

Synthetic

ImpurityProfile

ImpurityA|1-ethyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylicacid(demethylatedpefloxacinornorfloxacin)|70458-96-7|C₁₆H₁₈FN₃O₃|319.331|ImpurityB|6-chloro-1-ethyl-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylicacid(chlorinatedhomologueofpefloxacin)||C₁₇H₂₀ClN₃O₃|349.81|ImpurityE|1-ethyl-6-fluoro-7-(4-methylpiperazin-1-yl)quinoline-4(1H)-one(decarboxylatedpefloxacin)||C₁₆H₂₀FN₃O_{|389.35|ImpurityD|4-(3-carboxy-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinolin-7-yl)-1-methylpiperazine1-oxide(N-oxideofpefloxacin)|85145-21-7|C17H20FN3O4|349.36|ImpurityC|1-ethyl-6-fluoro-5-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylicacid(isopefloxacin)|70458-92-3|C17H20FN3O3|333.36|ImpurityF|7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylicacid(N-ethylacid)(norfloxacinimpurityA)||C12H9ClFNO3|269.66|ImpurityG|ethyl7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate(N-ethylester)||||ImpurityH|5-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylicacid(iso-N-ethylacid)|}

pH

3.5-4.5

MeltingPoint

271°C

Assay

≥99.0%

LossonDrying

≤8.5%