Tofacitinib Impurity 42 (CAS 90213-66-4) es una impureza relacionada de proceso identificada durante la síntesis y control de calidad de tofacitinib | caracterizada por su masa molecular única y patrón de fragmentación en espectrometría de masas. Su seguimiento mediante HPLC con detección a UV y LC-MS permite cuantificación precisa por debajo de los límites de especificación. Estudios de degradación forzados han definido su formación por rutas de reacción secundarias y condiciones de almacenamiento. La evaluación técnico-regulatoria incluye perfil toxicológico | límites de aceptación según ICH Q3A y estrategias de mitigación en la etapa de purificación para asegurar la seguridad y consistencia del producto final.
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