El impuro Sofosbuvir Impurity 13 (CAS 119410-95-6) es un subproducto estructuralmente relacionado con el fármaco activo generado durante etapas de síntesis o degradación. Presenta modificaciones en el nucleósido y el grupo fosfato que afectan la polaridad y el perfil cromatográfico. Su identificación y cuantificación requieren técnicas analíticas validadas como HPLC-UV | LC-MS y RMN para caracterizar masa | fragmentación y entornos protones/carbonos. Desde la perspectiva regulatoria debe ser monitorizado conforme a guías ICH | estableciendo límites de aceptación y estrategias de control de proceso. El conocimiento de su ruta de formación ayuda a optimizar condiciones de reacción y minimizar su presencia en materiales de referencia.
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