Fenofibrate EP Impurity E (CAS 42019-08-9) | también denominada Fenofibrate Ethyl Ester Analog | es una impureza estructural relevante en lotes de fenofibrato documentada en la Farmacopea Europea. Su caracterización analítica se realiza mediante HPLC con detección UV y LC-MS para confirmación de masa y espectroscopía NMR para elucidación estructural. La presencia de esta impureza puede afectar especificaciones de pureza y estabilidad del principio activo por lo que se establece como marcador crítico en ensayos de control de calidad. Se recomiendan métodos validados con límites de cuantificación adecuados y uso de material de referencia para establecer criterios de aceptación y cumplimiento regulatorio.
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