A impureza N-metilftalimida de rivaroxabana é uma impureza de գործընթացo de natureza imídica aromática associada à rota sintética da rivaroxabana, sem correspondência com um motivo farmacologicamente ativo. O material, CAS 550-44-7, apresenta fórmula C9H7NO2 e massa molecular de 161,16 g/mol, compatível com a formação de N-alquilftalimidas a partir de derivados de anidrido ftálico durante etapas de proteção ou aminação. Essas espécies são geralmente interpretadas como subprodutos de síntese ou como evidência de conversão incompleta. A identificação e a quantificação exigem, em geral, LC-MS/MS, espectrometria de massas de alta resolução e confirmação ortogonal por HPLC ou GC-MS. A avaliação insere-se no contexto de perfis de impurezas conforme ICH Q3A.
Referências
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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