Sofosbuvir Impurity 117 (CAS 1392015-05-2) é uma impureza relacionada ao processo de síntese de sofosbuvir | caracterizada por variações estruturais detectáveis por LC-MS e NMR. Seu perfil analítico requer métodos validados de HPLC com detectores UV e espectrometria de massa para quantificação de traços e estabelecimento de limites de aceitação. A presença desta impureza influencia a pureza fármacopeica | estabilidade do lote e cumprimento de especificações regulatórias | exigindo investigação de origem | estudos de forçamento e estratégias de controle no processo. Fornece material de referência para desenvolvimento analítico | resolução de desvios e garantia da qualidade do ingrediente ativo.
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