Tofacitinib Impurity 121 CAS 1228879-37-5

Description

The occurrence of Tofacitinib Impurity 121 is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Tofacitinib Impurity 121 (CAS 1228879-37-5) is a certified pharmaceutical impurity reference standard with the molecular formula C14H22N2HCl and a molecular weight of 254.80 g/mol.

Tofacitinib Impurity 121 (C14H22N2HCl) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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