Impureza do éster isopropílico do sacubitril encontrada como impureza relacionada no processo de síntese e degradação do princípio ativo | exigindo caracterização estrutural e quantificação rigorosa. Esta impureza é detectada e monitorada por HPLC com detecção UV | confirmada por LC-MS e NMR para elucidação de massa e conectividade. Pode originar-se por transesterificação ou esterificação incompleta e por hidrólise sob condições de processo e armazenamento | impactando o perfil de impurezas e limites de especificação. Estratégias de controle incluem otimização de etapas sintéticas | etapas de purificação e testes de estabilidade conforme diretrizes ICH | assegurando conformidade para liberação de lote.
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