Impureza identificada en Fenofibrate CRS (F0048000) | CAS 49562-28-9 | diseñada como estándar de referencia para el control del perfil de impurezas relacionadas; compuesta estructuralmente cercana al API | aporta un punto de referencia para la identificación y cuantificación mediante HPLC | LC-MS y detectores UV | permitiendo determinar factores de respuesta | tiempos de retención y límites de aceptación. Su uso facilita la evaluación de estabilidad frente a estrés ácido | básico y oxidativo | la caracterización de productos de degradación y la validación de métodos analíticos. Se suministra con certificado de análisis que documenta pureza | trazabilidad y datos espectrales necesarios para cumplimiento de especificaciones.
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