Norfloxacin EP Impurity B (CAS 1797116-86-9) es una impureza estructural resultante de la pérdida de un fragmento etileno en la ruta sintética de norfloxacino | descrita también como Norfloxacin Desethylene Impurity o Norfloxacin Ethylene Diamine Analogue HCl salt. Presenta propiedades fisicoquímicas distintas al principio activo | frecuentemente como sal de clorhidrato | y puede influir en el perfil de impurezas y en los parámetros de estabilidad. Su identificación y cuantificación se realiza mediante HPLC con detección UV | espectrometría de masas para confirmación de m/z y resonancia magnética para verificación estructural. Es crítico definir límites de especificación y procedimientos de control en conformidad con EP.
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