Ertapenem Impurity 20 CAS CATO-C4X-163320

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ertapenem Impurity 20.

CATO supplies Ertapenem Impurity 20 (CAS CATO-C4X-163320), a pharmacopoeial impurity reference standard (molecular formula C44H48N6O13S2, MW 933.01 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Ertapenem Impurity 20 (C44H48N6O13S2) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. 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 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), Ertapenem Impurity 20 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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