(S, Z)-7-(2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-5-hydroxyhept-2-enoic acid, sodium salt (1:1)
Sinônimos
N/A
Descrição
Impureza Atorvastatin 3-Deoxyhept-2Z-Enoic Acid (Na Salt) (CAS 1659317-56-2) é um subproduto oxidativo/deidratado observado na síntese de atorvastatina. Caracteriza-se por perda do grupo hidroxila no carbono 3 e dupla ligação Z na cadeia heptenoica | apresentando maior polaridade como sal de sódio. A impureza afeta atributos críticos de qualidade incluindo pureza de lote e perfil de estabilidade. É quantificada por HPLC-MS e confirmada por 1H/13C NMR e espectrometria de massas. Métodos analíticos validados com limites de detecção baixos e estratégias de controle como otimização de condições reacionais | purificação e monitoramento in-process são recomendados para garantir conformidade com diretrizes regulatórias.
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