Saxagliptin Impurity 22 CAS CATO-C4X-104922

Description

The occurrence of Saxagliptin Impurity 22 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Saxagliptin Impurity 22 (CAS CATO-C4X-104922) is a certified pharmaceutical impurity reference standard with the molecular formula C13H22N2O3 and a molecular weight of 254.33 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Saxagliptin Impurity 22 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 254.33 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.

CATO manufactures Saxagliptin Impurity 22 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

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