Impureza 2’S-?-Fluoro tribenzoyl sofosbuvir intermedio se identifica como un subproducto de s?ntesis relevante para el control de calidad; presenta perfil cromatogr?fico y masas moleculares que requieren monitorizaci?n por HPLC-UV | LC-MS y RMN para confirmar estructura y cuantificar niveles por debajo de la especificaci?n. Su presencia puede afectar atributos de calidad como pureza qu?mica y estabilidad del intermedio | por lo que se establecen l?mites aceptables y procedimientos de eliminaci?n mediante cromatograf?a de fase normal o inversa y optimizaci?n de condiciones de reacci?n. Se recomiendan m?todos anal?ticos validados | estudios de degradaci?n forzados y trazabilidad documental para cumplir normativa y garantizar consistencia del proceso.
Referencias
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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