A impureza pirrolidinona (3R,5S) de sacubitril, também descrita como impureza cíclica de sacubitril, corresponde a um produto de rearranjo estrutural com anel lactâmico, fórmula molecular C18H19NO, massa molecular 265.35 g/mol e CAS 1038924-70-7. Esta espécie é compatível com ciclização intramolecular ou via secundária de síntese, podendo surgir durante o processamento de intermediários ou durante o armazenamento sob condições que favoreçam o fechamento de anel. Devido ao arcabouço não clássico e à proximidade estrutural com o fármaco, o controlo em nível de traço requer caracterização ortogonal por LC-MS/MS, espectrometria de massas de alta resolução e perfilamento por HPLC com confirmação por RMN após isolamento. Trata-se de um tema de entendimento de processo e qualificação de impurezas.
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