Indapamida EP Impureza C (CAS 31529-46-1) es una impureza relacionada crítica identificada en el perfil de calidad del principio activo. Su caracterización incluye determinación de identidad y cuantificación mediante HPLC con detección UV y confirmación por espectrometría de masas MS y RMN. Se evalúan su origen por degradación o síntesis y su potencial impacto sobre la seguridad del lote. Los procedimientos analíticos validados establecen límites de aceptación | criterios de resolución cromatográfica y parámetros de recuperación. El control en proceso y los estudios de estabilidad permiten monitorizar la formación de esta impureza y asegurar cumplimiento de especificaciones regulatorias.
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