Tofacitinib 5-Oxo Impurity; Tofacitinib Related Substance 8;
Descripción
3-((3R | 4R)-4-Metil-3-(metil(5-oxo-6 | 7-dihidro-5H-pirrolo[2 | 3-d]pirimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrilo | CAS: 2101951-20-4 | conocido como Tofacitinib 5-Oxo Impurity o Tofacitinib Related Substance 8 | es una impureza relevante en el control de calidad de tofacitinib; incorpora un grupo ceto y un nitrilo enlazados a un anillo piperidínico y un núcleo pirrolopirimidínico | características que favorecen su aparición por oxidación parcial o rutas de reacción secundarias durante síntesis y almacenamiento. Su identificación y cuantificación requieren HPLC con detección adecuada | LC-MS y RMN para confirmar estructura y niveles. El manejo efectivo incluye optimización del proceso | etapas de purge | límites en especificación y estudios de estabilidad para mitigar riesgos sobre la calidad y seguridad del producto final.
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