Impureza Eltrombopag N-Oxide (CAS 2734533-17-4) es un N-óxido generado por oxidación del nitrógeno en la molécula de eltrombopag | presentando un incremento de masa de +16 Da respecto al API. Su presencia se considera crítica para el control de calidad debido a posible impacto en pureza | perfil de degradación y cumplimiento de especificaciones ICH Q3A/Q3B. La identificación y cuantificación se realiza mediante HPLC acoplada a MS y confirmación por RMN y espectrometría de masas; muestra retención y polaridad alteradas frente al compuesto progenitor. Estrategias de mitigación incluyen pruebas de estrés oxidativo | condiciones de síntesis bajo atmósfera inerte y uso de antioxidantes en formulaciones.
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