Tafamidis Impurity 4 CAS CATO-C4X-28774

Description

The occurrence of Tafamidis Impurity 4 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Tafamidis Impurity 4 (CAS CATO-C4X-28774), a pharmacopoeial impurity reference standard (molecular formula C9H9Cl2NO, MW 218.08 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Tafamidis Impurity 4 (C9H9Cl2NO) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. 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), Tafamidis Impurity 4 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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