Tegoprazan Impurity 76 CAS CATO-C4X-229776

Description

The occurrence of Tegoprazan Impurity 76 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Tegoprazan Impurity 76 (CAS CATO-C4X-229776), a pharmacopoeial impurity reference standard (molecular formula C36H31F4N3O4, MW 645.64 g/mol) used for the identification and quantification of trace impurities in APIs.

Tegoprazan Impurity 76 (C36H31F4N3O4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Tegoprazan Impurity 76 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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