Impureza benzil de tofacitinib (CAS 477600-73-0) | conocida como Tofacitinib Inhouse Impurity B o Des-(N-oxopropanenitrilo)-N-metilbenzil | es una impureza de proceso detectada durante la síntesis del principio activo. Presenta alteraciones en el fragmento benzílico y la pérdida del grupo N-oxopropanenitrilo que pueden influir en la estabilidad y el perfil impuritario del lote. Su identificación y cuantificación requieren técnicas analíticas robustas como HPLC con detección UV | LC-MS y RMN para confirmación estructural. La monitorización en etapa de desarrollo y la optimización de condiciones de reacción son esenciales para controlar su formación y garantizar cumplimiento de los requisitos de calidad farmacéutica.
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