Sitagliptin Impurity 64 CAS 877402-43-2

Description

Compared with other compounds in its class, the molecular weight of 292.26 g/mol gives Sitagliptin Impurity 64 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Sitagliptin Impurity 64 (CAS 877402-43-2), a pharmacopoeial impurity reference standard (molecular formula C11H15F3N4O2, MW 292.26 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, fluorine substitution, Sitagliptin Impurity 64 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 292.26 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 Sitagliptin Impurity 64 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?

• ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
• 130,000+ catalog items in stock, COA supplied with every batch
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• Technical support: +86 18665070610 / Nicole.chen@cato-chem.com