Impureza de Fenofibrato 4 (CAS 1797121-54-0) | conocida también como Fenofibric Acid 1-Carboxyl-1-methylethyl Ester | es una impureza relacionada con la síntesis y degradación de fenofibrato que requiere caracterización rigurosa en control de calidad. Esta impureza se identifica y cuantifica mediante técnicas analíticas avanzadas como HPLC con detección UV | LC-MS para confirmación de masa y espectroscopía de RMN para asignación estructural. Su presencia afecta el perfil de impurezas del principio activo y demanda referencia analítica para validación de métodos | estudios de estabilidad y cumplimiento de especificaciones regulatorias | garantizando trazabilidad y robustez en procesos farmacéuticos.
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