Saxagliptin Impurity C628 CAS 361442-01-5

Description

Compared with other compounds in its class, the molecular weight of 433.54 g/mol gives Saxagliptin Impurity C628 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Saxagliptin Impurity C628 (CAS 361442-01-5, C23H35N3O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Saxagliptin Impurity C628 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 433.54 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

As a certified reference material (CRM), Saxagliptin Impurity C628 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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