Tetrabenazine Impurity 29-D6 CAS CATO-C4X-274829

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Tetrabenazine Impurity 29-D6.

CATO supplies Tetrabenazine Impurity 29-D6 (CAS CATO-C4X-274829), a pharmacopoeial impurity reference standard (molecular formula C19H23D6NO3, MW 325.48 g/mol) used for the identification and quantification of trace impurities in APIs.

Tetrabenazine Impurity 29-D6 (C19H23D6NO3) contains deuterium isotope labeling, a steroid core, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

As a certified reference material (CRM), Tetrabenazine Impurity 29-D6 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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