La impureza N-metilftalimida de rivaroxabán es una impureza de proceso de tipo imida aromática asociada a la ruta de síntesis de rivaroxabán y no a un motivo farmacológicamente activo. El material, CAS 550-44-7, corresponde a C9H7NO2 con un peso molecular de 161,16 g/mol, y es coherente con la formación de N-alquilftalimidas a partir de derivados de anhídrido ftálico durante etapas de protección o aminación. Estas especies suelen interpretarse como subproductos de síntesis o como marcadores de conversión incompleta. Su identificación y cuantificación requieren habitualmente LC-MS/MS, espectrometría de masas de alta resolución y confirmación ortogonal por HPLC o GC-MS. Su evaluación se sitúa en el marco de ICH Q3A y del perfilado estructural de impurezas.
Referencias
Vimalesvaran, Kavitha, et al. “Role of Rivaroxaban in the Management of Atrial Fibrillation: Insights from Clinical Practice.” Vascular Health and Risk Management, vol. Volume 14, Jan. 2018, pp. 13–21, https://doi.org/10.2147/vhrm.s134394.
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