Pregabalin impurity 95 CAS 164597-78-8

Description

Compared with other compounds in its class, the molecular weight of 155.19 g/mol gives Pregabalin impurity 95 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Pregabalin impurity 95 (CAS 164597-78-8), a pharmacopoeial impurity reference standard (molecular formula C8H13NO2, MW 155.19 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C8H13NO2, Pregabalin impurity 95 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 155.19 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).

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), Pregabalin impurity 95 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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