Norfloxacin Desethylene Impurity; Norfloxacin Ethylenediamine Analog (Free Base); 7-[(2-Aminoethyl)amino]-1-ethyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid
Descripción
Impureza Norfloxacin EP Impurity B (CAS 75001-77-3) es un derivado desetileno del norfloxacino | también reportado como Norfloxacin Desethylene Impurity o análogo etilendiamina libre base y descrito como 7-[(2-aminoetil)amino]-1-etil-6-fluoro-1 | 4-dihidro-4-oxo-3-quinolinacarboxílico. Esta impureza presenta características fisicoquímicas y espectrales que la convierten en un marcador crítico en el control analítico | con implicaciones en pureza | estabilidad y especificaciones del producto final. Se recomienda su monitoreo mediante HPLC con detección UV y confirmación por espectrometría de masas para establecer límites | estudios de degradación y validar métodos de cuantificación conforme a monografías EP y buenas prácticas analíticas.
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