2′-Hydroxy Sofosbuvir é uma impureza relevante no perfil de qualidade de lotes de Sofosbuvir que exige monitoramento analítico rigoroso. Caracteriza-se por alteração estrutural no anel ribosídeo que pode afetar pureza e estabilidade do produto final. A identificação e quantificação são normalmente realizadas por HPLC acoplada a detectores UV e LC-MS para confirmação de massa | complementadas por RMN para elucidação estrutural. Estudos de forçadas e validação de métodos determinam sua formação durante síntese e armazenamento | permitindo estabelecer limites aceitáveis e estratégias de controle de processo. A documentação robusta deste contaminante é essencial para conformidade regulatória e liberação de lotes.
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