Fenilefrina Impurity 6 (sal de HCl) es una impureza identificada en lotes de fenilefrina que requiere evaluación rigurosa en el control de calidad. Su descripción analítica incluye propiedades fisicoquímicas | perfil cromatográfico y masa molecular esperada | lo que facilita su identificación por HPLC | LC-MS y NMR. Se recomienda establecer límites de aceptación | límites de detección y métodos de cuantificación validados conforme a ICH Q3A y Q3B para garantizar seguridad y eficacia del producto final. La trazabilidad del material de referencia | la estabilidad en condiciones de almacenamiento y la evaluación de posibles rutas de formación durante síntesis y purificación son críticas para la gestión de riesgo.
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