Roxadustat Impurity 13 (CAS 1809286-36-9) es una impureza relacionada detectada durante la síntesis y el control de calidad de roxadustat. Se caracteriza por un perfil cromatográfico definido y firmas espectrométricas detectables por LC-MS y NMR, y su identificación y cuantificación son esenciales para el cumplimiento de especificaciones y estudios de estabilidad. Los métodos analíticos deben ser indicativos de estabilidad y capaces de separar esta impureza de los componentes principales; se recomienda empleo de HPLC con detectores UV y MS, validación del límite de cuantificación y pruebas de degradación forzada para evaluar su formación. La monitorización permite la gestión del proceso y la mitigación de riesgos de calidad.
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