Saxagliptin Impurity 13 CAS CATO-C4X-104913

Description

The occurrence of Saxagliptin Impurity 13 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Saxagliptin Impurity 13 (CAS CATO-C4X-104913) is a certified pharmaceutical impurity reference standard with the molecular formula C18H25N3O2 and a molecular weight of 315.41 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Saxagliptin Impurity 13 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 315.41 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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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