Bempedoic Acid Impurity 10 CAS CATO-C4X-218910

Description

The occurrence of Bempedoic Acid Impurity 10 is closely related to a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Bempedoic Acid Impurity 10 (CAS CATO-C4X-218910), a pharmacopoeial impurity reference standard (molecular formula C16H24O5S, MW 328.42 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Bempedoic Acid Impurity 10 (C16H24O5S) is characterized by a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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), Bempedoic Acid Impurity 10 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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