Rivaroxaban Impurity II (CAS 85-41-6) | también registrada como o-Phthalic imide; 1 | 3-Isoindolinedione; 1 | 2-Benzenedicarboximide; 1 | 3-Isoindoledione | es una impureza estructural derivada del núcleo isoinodolínico. Se caracteriza por su armazón imídico aromático y se detecta rutinariamente por HPLC con detector UV | LC-MS y confirmación por RMN 1H/13C. Desde el punto de vista regulatorio representa un punto crítico de control por su posible impacto en la pureza del principio activo | por lo que se establecen límites cuantitativos en especificaciones y procedimientos de limpieza y purificación para reducir su presencia. Estudios de degradación y validación analítica son recomendables para el control robusto.
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