2′-Alkene Sofosbuvir (CAS 2095551-20-3) é uma impureza relevante no controle de qualidade de Sofosbuvir | caracterizada por uma insaturação no carbono 2′ do nucleosídeo. Apresenta propriedades físico-químicas distintas que podem afetar pureza | estabilidade e perfil de degradação do ativo. Métodos analíticos sensíveis como HPLC com detecção UV | LC-MS e NMR são recomendados para identificação | quantificação e elucidação estrutural. Estudos de formação indicam vias de eliminação de grupos protetores e reações de desidratação sob condições ácidas ou térmicas. A determinação de limites de especificação e validação de métodos são essenciais para garantir conformidade regulatória e segurança do processo farmacêutico.
Referências
‌Bhatia, H. K., Singh, H., Grewal, N., & Natt, N. K. (2014). Sofosbuvir: A novel treatment option for chronic hepatitis C infection. Journal of Pharmacology and Pharmacotherapeutics, 5(4), 278–284. https://doi.org/10.4103/0976-500x.142464 ‌
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