Sofosbuvir Impurity 2 (CAS 863329-62-8) es un subproducto estructuralmente relacionado que se forma durante la síntesis o la degradación del principio activo; su detección y cuantificación son críticas para el control de calidad. Presenta desafíos analíticos en el perfil de impurezas por posible coelución y semejanza espectral | por lo que requiere identificación y cuantificación mediante HPLC con detección UV y confirmación por LC-MS y RMN. Su presencia puede influir en la estabilidad y pureza del lote | por lo que se implementan límites especificados | estudios de degradación forzada y métodos analíticos validados para gestionar el riesgo conforme a guías ICH.
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