2 | 5-Dioxopyrrolidine Sacubitril (CAS 1038924-97-8) é uma impureza relevante no perfil de controlo de qualidade de matérias-primas e produtos intermediários relacionados a sacubitril. Identificada como subproduto de síntese e potencial produto de degradação | requer caracterização por HPLC | LC-MS e RMN para confirmação estrutural e quantificação. A presença desta impureza pode afetar especificidade analítica e estabilidade do lote | sendo necessário estabelecer limites | métodos de limpeza de processo e estudos de degradação forçada para mapear vias de formação. Recomenda-se monitorização contínua | desenvolvimento de métodos validados e inclusão em especificações de impurezas para garantir conformidade regulatória.
Referências
Nicolas, Diala, et al. “Sacubitril/Valsartan.” Nih.gov, StatPearls Publishing, 9 May 2022, www.ncbi.nlm.nih.gov/books/NBK507904/.
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