Tofacitinib Amine Impurity\Tofacitinib Inhouse Impurity A
Descripción
La impureza N-descyanoacetilo de tofacitinib, también denominada impureza amina de tofacitinib, es un residuo de intermedio sintético relacionado con el proceso y asociado al ensamblaje de la cadena lateral de tofacitinib. CAS 477600-74-1, fórmula molecular C13H19N5 y peso molecular 245.32 g/mol, describen una amina heteroaromática básica carente de la funcionalidad cianoacetilo del intermedio de ruta original. Habitualmente se vigila como impureza de proceso derivada de acilación incompleta, desprotección o conversión hidrolítica durante la fabricación. Su cuantificación suele requerir LC-MS/MS, LC-UV con confirmación ortogonal y, en ocasiones, HRMS para resolver especies amínicas estructuralmente afines bajo criterios de control de impurezas alineados con ICH Q3A e ICH M7.
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