Impureza Apixaban 126 es un perfil de impureza crítica identificada durante la síntesis y el control de calidad del principio activo apixabán; su estructura presenta modificaciones en el núcleo heterocíclico que afectan polaridad y cromatografía. Se caracteriza por análisis por LC-MS | HPLC con detección UV y confirmación por RMN; presenta tendencia a formarse por reacciones secundarias en condiciones ácidas o por degradación térmica. Su presencia puede alterar la pureza | perfil de impurezas trazas y parámetros de estabilidad | por lo que se recomienda desarrollar métodos analíticos validados | límites de aceptación basados en toxicología | estrategias de purificación y control de proceso para minimizar su formación.
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