Brivaracetam impurity 101 CAS CATO-C4X-2007101

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Brivaracetam impurity 101.

CATO supplies Brivaracetam impurity 101 (CAS CATO-C4X-2007101), a pharmacopoeial impurity reference standard (molecular formula C8H13NO2, MW 155.19 g/mol) used for the identification and quantification of trace impurities in APIs.

Brivaracetam impurity 101 (C8H13NO2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Brivaracetam impurity 101 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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