Impureza 3 de Acalabrutinib | (S)-benzyl 2-(8-amino-6-bromoimidazo[1 | 5-a]pyrazin-3-yl)pyrrolidine-1-carboxylate | es una impureza relacionada detectada durante síntesis y almacenamiento que presenta un núcleo imidazo-pirazínico bromado y un fragmento con centro estereoquímico S en la pirrolidina; su caracterización analítica se obtiene mediante HPLC con detección UV y confirmación por LC-MS y RMN para determinar masa exacta | patrones de fragmentación y configuración. La presencia requiere evaluación del perfil de impurezas | establecimiento de límites de especificación y estudios de estabilidad y degradación según ICH. El control mediante optimización de la síntesis y purificación es esencial para garantizar la calidad farmacéutica y el cumplimiento regulatorio.
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