Fenofibrate EP Impurity F (CAS 154356-96-4) | también conocida como Fenofibrate Ether o (4-clorofenil)-(4-propan-2-yloxifenil)metanona | es una impureza clorada tipo benzofenona relevante en el control de calidad de fenofibrato conforme a la Farmacopea Europea; su presencia puede afectar la pureza y perfil toxicológico del lote. Desde el punto de vista técnico presenta un anillo aromático clorado y un grupo isopropoxi que incrementan lipofilia y estabilidad frente a hidrólisis | por lo que su eliminación puede requerir ajustes de purificación. Se recomienda detección y cuantificación mediante HPLC con detector UV y confirmación por LC-MS para establecer límites y criterios de aceptación.
Referencias
Miranda, Miguel A., et al. “PHOTOSENSITIZATION by FENOFIBRATE. II. In Vitro PHOTOTOXICITY of the MAJOR METABOLITES.â€Â Photochemistry and Photobiology, vol. 59, no. 2, Feb. 1994, pp. 171–74, https://doi.org/10.1111/j.1751-1097.1994.tb05018.x.
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