Darolutamide Impurity 1 (CAS 2407645-49-0) es una impureza estructuralmente relacionada con la molécula activa | identificada como 1H-pirazol-3-carboxamida N-[(1R)-2-[3-(3-cloro-4-cianofenil)-1H-pirazol-1-il]-1-metiletil]-5-(1-hidroxietil)-. Tiene importancia en control de calidad por su formación durante etapas sintéticas y almacenamiento | ya que puede alterar la pureza | el perfil de impurezas y propiedades fisicoquímicas del lote. Se caracteriza mediante NMR | LC-MS y HPLC con condiciones y retención específicas. Los estudios incluyen rutas de degradación | parámetros de generación | solubilidad y estabilidad frente a oxidación. Es necesario establecer límites analíticos | métodos validados de cuantificación e identificación para cumplimiento regulatorio.
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