O isômero Tofacitinib (3S,4R), CAS 1092578-48-7, é uma impureza estereoisomérica do inibidor de JAK tofacitinib, podendo originar-se por inversão configuracional durante a síntese ou por epimerização sob condições ácidas, térmicas ou cromatográficas. Com fórmula molecular C16H20N6O e massa molecular de 312.37 g/mol, não se trata de um nitrosamino, mas de uma impureza quiral relacionada ao processo, de relevância regulatória, pois a estereoquímica alterada pode modificar a seletividade farmacológica e o perfil de impurezas. A detecção e quantificação exigem tipicamente HPLC quiral acoplada a LC-MS/MS, e a confirmação pode empregar RMN ou MS de alta resolução. A avaliação se enquadra em ICH Q3A e no controle estereoquímico.
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