Vildagliptin Impurity 54 CAS 16104-28-2

Description

The occurrence of Vildagliptin Impurity 54 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Vildagliptin Impurity 54 (CAS 16104-28-2, C10H16O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, Vildagliptin Impurity 54 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 200.23 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.

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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