Apixaban Impurity 120 es una impureza estructural identificada durante la síntesis y el control de calidad de apixaban; presenta un perfil cromatográfico consistente | detectable por HPLC-UV y confirmable por LC-MS y RMN para asignación estructural. Su aparición suele asociarse a reacciones laterales en etapas de acoplamiento o a degradación en condiciones ácidas o oxidativas. Característicamente muestra menor polaridad que el compuesto principal y un tiempo de retención diferenciado en métodos UHPLC | lo que facilita su cuantificación. Su caracterización y establecimiento de límites en especificación son esenciales para asegurar calidad | estabilidad y cumplimiento regulatorio | además de definir estrategias de mitigación en el proceso.
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