Sitagliptin EP Impurity B CAS 486460-31-5

Description

Compared with other compounds in its class, the molecular weight of 389.32 g/mol gives Sitagliptin EP Impurity B distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Sitagliptin EP Impurity B (CAS 486460-31-5), a pharmacopoeial impurity reference standard (molecular formula C16H16F5N5O, MW 389.32 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Sitagliptin EP Impurity B (C16H16F5N5O) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Sitagliptin EP Impurity B 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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