O isómero Tofacitinib (3R,4S), CAS 1092578-46-5, é uma impureza estereoisomérica do esqueleto inibidor de Janus quinase, e não uma nova entidade constitucional. Com fórmula molecular C16H20N6O e massa molar de 312.37 g/mol, difere da forma ativa pela inversão nos centros estereogênicos da pirrolidina e pode surgir durante a síntese assimétrica, por epimerização ou por deriva estereoquímica nas condições de प्रक्रिया. Sua caracterização normalmente requer LC quiral ortogonal, LC-MS/MS e, quando necessário, RMN para distingui-la de isômeros relacionados. O enquadramento regulatório concentra-se no perfil de impurezas e no controle da pureza estereoquímica conforme os princípios de ICH Q3A e Q6A.
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