Amiodarone N-Oxide Impurity (CAS: 318267-30-0) | conocida como impureza N-óxido de amiodarona | es un derivado oxidado formado por la transformación del nitrógeno terciario del principio activo; su aparición se registra en degradación por oxidación | durante etapas de síntesis o por almacenamiento inadecuado. Presenta mayor polaridad y un incremento de masa aproximado de +16 Da frente al compuesto progenitor | lo que altera su comportamiento cromatográfico. La identificación y cuantificación precisas requieren técnicas sensibles como LC-MS y HPLC debidamente validadas. El monitoreo en estudios de estabilidad y la inclusión en especificaciones analíticas son claves para controlar su nivel y preservar la calidad del lote.
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