Rivaroxaban Impurity 97 (CAS 2422046-61-3) es una impureza relacionada detectada en el proceso de síntesis y en estudios de estabilidad de rivaroxabán. Su perfil analítico incluye solubilidad | punto de fusión y espectros IR | NMR y LC-MS necesarios para su identificación y cuantificación en trazas. Es crítico para control de calidad y desarrollo de métodos por HPLC y UPLC con validación de límites de detección y cuantificación | precisión y especificidad. La monitorización de esta impureza contribuye a evaluar rutas de degradación | optimizar procesos sintéticos y garantizar cumplimiento regulatorio en farmacéutica | minimizando riesgos de seguridad y variabilidad del producto final.
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