Form
Powder
Appearance
Cream colored powder
Source
Synthetic
Impurity Profile
Impurity A| 1-ethyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid (demethylated pefloxacin or norfloxacin)|70458-96-7|C16H18FN3O3|319.331| Impurity B| 6-chloro-1-ethyl-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (chlorinated homologue of pefloxacin)||C17H20ClN3O3|349.81| Impurity E| 1-ethyl-6-fluoro-7-(4-methylpiperazin-1-yl)quinoline-4(1H)-one (decarboxylated pefloxacin)||C16H20FN3O|389.35| Impurity D| 4-(3-carboxy-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinolin-7-yl)-1-methylpiperazine 1-oxide (N-oxide of pefloxacin)|85145-21-7|C17H20FN3O4|349.36| Impurity C| 1-ethyl-6-fluoro-5-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (isopefloxacin)|70458-92-3|C17H20FN3O3|333.36| Impurity F| 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (N-ethyl acid) (norfloxacin impurity A)||C12H9ClFNO3|269.66| Impurity G| ethyl 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate (N-ethyl ester)|||| Impurity H| 5-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (iso-N-ethyl acid)|
pH
3.5-4.5
Melting Point
271°C
Assay
≥99.0%
Loss on Drying
≤8.5%