Tofacitinib Impurity 59 (CAS 1616760-97-4) es una impureza relacionada estructuralmente con el principio activo que requiere identificación | caracterización y cuantificación en el perfil de impurezas. Su detección se realiza típicamente por HPLC acoplado a detectores UV y espectrometría de masas de alta resolución para determinar masa exacta y fragmentación | complementada por RMN e IR para confirmación estructural. Es relevante evaluar su origen en rutas de síntesis | intermediarios o degradación durante estrés térmico | fotolítico o en presencia de agentes oxidantes. El control mediante límites especificados y estudios de justificación según guías regulatorias garantiza seguridad y calidad del producto final.
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