Tofacitinib Amine Impurity\Tofacitinib Inhouse Impurity A
Description
Tofacitinib N-Descyanoacetyl Impurity, also designated Tofacitinib Amine Impurity, is a process-related synthetic intermediate residual associated with the construction of the tofacitinib side chain. CAS 477600-74-1, molecular formula C13H19N5, molecular weight 245.32 g/mol, identifies a basic heteroaromatic amine lacking the cyanoacetyl functionality of the parent route intermediate. It is typically monitored as a route impurity arising from incomplete acylation, deprotection, or hydrolytic conversion during manufacture. Quantification generally requires LC-MS/MS, LC-UV with orthogonal confirmation, and sometimes HRMS to resolve it from structurally related amine species under impurity control strategies aligned with ICH Q3A and M7 principles.
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