El 3′-S isómero de Sofosbuvir es una impureza estereoquímica crítica que impacta el perfil de calidad del principio activo. Su identificación y cuantificación mediante HPLC y espectrometría de masas es esencial para cumplir especificaciones regulatorias. Presenta propiedades fisicoquímicas ligeramente distintas al isómero esperado | incluyendo cambios en polaridad y comportamiento en pruebas de estabilidad | lo que puede afectar la retención y el patrón de degradación. Se requiere caracterización completa | establecimiento de límites de aceptación y métodos analíticos validados para control en procesos de síntesis y purificación. La detección temprana y el monitoreo continuo reducen riesgos de variabilidad y aseguran consistencia del lote.
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