Tofacitinib Impurity 16 CAS 2328165-36-0

Description

Compared with other compounds in its class, the molecular weight of 331.37 g/mol gives Tofacitinib Impurity 16 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Tofacitinib Impurity 16 (CAS 2328165-36-0, C16H21N5O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Tofacitinib Impurity 16 (C16H21N5O3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 331.37 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

As a certified reference material (CRM), Tofacitinib Impurity 16 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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