Sitagliptin Impurity 119 CAS 2114328-77-5

Description

Compared with other compounds in its class, the molecular weight of 278.14 g/mol gives Sitagliptin Impurity 119 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Sitagliptin Impurity 119 (CAS 2114328-77-5, C10H5F3O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Sitagliptin Impurity 119 (C10H5F3O6) contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

As a certified reference material (CRM), Sitagliptin Impurity 119 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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