Impureza de Aliskiren-D6 hemifumarato presenta un perfil isotópico y estructural crítico para el control analítico en procesos de síntesis. Se caracteriza por un desplazamiento de masa de +6 u respecto al análogo no marcado | afectando la resolución cromatográfica y la cuantificación por LC-MS/MS; por ello se exige una pureza isotópica elevada y límites de impurezas relacionadas definidos según ICH Q3A. Su estabilidad en solución y durante procesos de secado influye en la generación de productos de degradación y en la reproducibilidad analítica. Métodos validados como LC-MS/MS y RMN permiten determinar contenido | impurezas relacionadas y especificaciones de aceptación para garantizar trazabilidad y control de calidad.
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