Saxagliptin Impurity 64 HCl CAS CATO-C4X-104964

Description

The occurrence of Saxagliptin Impurity 64 HCl is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Saxagliptin Impurity 64 HCl (CAS CATO-C4X-104964), a pharmacopoeial impurity reference standard (molecular formula C18H24ClN3OHCl, MW 370.32 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Saxagliptin Impurity 64 HCl is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 370.32 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 64 HCl 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

Why CATO?

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