Vildagliptin Impurity N27 CAS 2253194-13-5

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Vildagliptin Impurity N27.

CATO supplies Vildagliptin Impurity N27 (CAS 2253194-13-5), a pharmacopoeial impurity reference standard (molecular formula C12H16N4O, MW 232.28 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Vildagliptin Impurity N27 is typically off-white to pale yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 232.28 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

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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