Acalabrutinib Impurity 2 | identificada como (S)-8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)-1-(4-(pyridin-2-ylcarbamoyl)phenyl)imidazo[1 | 5-a]pyrazine 7-oxide | es una impureza estructural relevante en el perfil de calidad de Acalabrutinib. Presenta un grupo óxido en el sistema imidazopyrazina que sugiere formación por oxidación durante síntesis o almacenamiento. Su monitorización analítica se realiza mediante HPLC con detección UV y LC-MS para confirmación de masa exacta | complementada por RMN para verificación estructural. La cuantificación robusta y los límites de aceptación específicos permiten evaluar su impacto en seguridad y estabilidad del lote. Se recomienda incluirla en métodos de control de calidad y estudios de degradación.
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