N-Nitroso Tofacitinib (Tofacitinib Nitroso Impurity 1) es una impureza N-nitrosa que puede formarse durante la síntesis o almacenamiento de tofacitinib mediante reacción con agentes nitrosantes. Desde el punto de vista técnico presenta relevancia por su potencial genotóxico y por la necesidad de detección sensible en control de calidad farmacéutico. Se recomienda monitoreo mediante técnicas analíticas como LC-MS/MS | GC-MS y HPLC con límites de detección validados | evaluación de purge y estudios de formación en condiciones de proceso. Las estrategias de control incluyen eliminación de fuentes nitrosantes | ajuste de pH | selección de disolventes y validación de pasos de purificación conforme a guías regulatorias aplicables.
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