Norfloxacin Impurity 16 (Trifluoroacetate) es una impureza de proceso y degradación relevante en el perfil de impurezas de norfloxacino | identificada y caracterizada por LC-MS y NMR. Como sal trifluoroacetato muestra un comportamiento cromatográfico distintivo con mayor polaridad y un tiempo de retención alterado en HPLC reverso. Su presencia puede indicar reacciones de salificación o contaminación por reactivos fluorados durante síntesis y purificación. Se recomienda control cuantitativo mediante métodos validados de HPLC-UV y LC-MS | establecimiento de límites de aceptación y estudios de estabilidad forzados para definir rutas de degradación | criterios de limpieza y estrategias de mitigación en control de calidad.
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