Intermedi?rio 2’S-?-fluoro-tribenzoyl de sofosbuvir apresenta-se como impureza de processo caracterizada por reten??o do grupo tribenzoyl e presen?a do substituinte fluoreto no carbono 2’S | podendo originar-se por benzoyla??o incompleta ou prote??es inadequadas durante a s?ntese. Esta impureza lipof?lica tende a coeluir em HPLC reverso e exige detec??o por LC-MS e 19F-NMR para confirma??o estrutural. A presen?a influencia perfil de pureza e estabilidade do composto ativo e requer estrat?gias anal?ticas validadas e controles de processo como purifica??o por recristaliza??o | cromatografia preparativa e otimiza??o de etapas de deprote??o | al?m de limites espec?ficos definidos conforme diretrizes regulat?rias para minimizar riscos toxicol?gicos e lotes fora de especifica??o.
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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