Fenofibrate EP Impurity D (CAS 42019-07-8) | también denominada Fenofibrate Methyl Ester Analog o Methyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-propanoate | es una impureza metílica derivada del grupo carboxílico del fenofibrato que presenta mayor lipofilicidad y menor polaridad que el ácido correspondiente; en cromatografía reversa muestra un tiempo de retención mayor y produce iones característicos en LC-MS | además de señales diagnósticas en NMR e IR. Se forma por esterificación secundaria o transesterificación durante síntesis y purificación | pudiendo afectar la pureza y la conformidad con especificaciones farmacopéyicas. Se recomienda monitoreo rutinario mediante métodos validados HPLC-UV y LC-MS para cuantificación y control de lote.
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