Impureza Sacubitril (2R | 4R)-Isomer (CAS 766480-48-2) | também conhecida como Sacubitril 4-epímero | resulta de epimerização no centro estereogênico C-4 e altera o perfil de impurezas. Exige monitoramento por técnicas analíticas sensíveis como HPLC quiral | LC-MS e RMN para quantificação e confirmação estrutural. A identificação detalhada permite avaliar vias de formação durante síntese e armazenamento | orientar otimização de processo e estabelecer critérios de aceitação para controle de qualidade. Dados de estabilidade e impurezas relacionadas são fundamentais para interpretar degradação e definir limites de especificidade em ensaios de pureza.
Referências
Kaplinsky, Edgardo. “Sacubitril/Valsartan in Heart Failure: Latest Evidence and Place in Therapy.†Therapeutic Advances in Chronic Disease, vol. 7, no. 6, Oct. 2016, pp. 278–90, https://doi.org/10.1177/2040622316665350. ?
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