Crizotinib Amine Impurity (CAS 877397-71-2) | conocida también como Crizotinib Impurity 4 o 3-[(1R)-1-(2 | 6-dichloro-3-fluorophenyl)ethoxy]pyridin-2-amine | es una impureza relacionada con el proceso de síntesis de crizotinib que contiene un grupo amina en posición 2 del heterociclo piridínico. Desde el punto de vista técnico | su identificación y cuantificación se realiza por HPLC-UV complementado con LC-MS y RMN para confirmar la configuración (1R) y la presencia de sustituyentes cloro y fluoro. Su control es crítico para cumplimiento regulatorio y para evaluar estabilidad | limpieza de proceso y necesidad de pasos de purificación adicionales como cromatografía preparativa o cristalinización.
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