Teneligliptin Impurity 51 CAS CATO-C4X-176051

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Teneligliptin Impurity 51.

CATO supplies Teneligliptin Impurity 51 (CAS CATO-C4X-176051), a pharmacopoeial impurity reference standard (molecular formula C45H60N12O2S2, MW 865.17 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C45H60N12O2S2, Teneligliptin Impurity 51 contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 865.17 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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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