Delgocitinib impurity 1 CAS CATO-C4X-33081

Description

The occurrence of Delgocitinib impurity 1 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Delgocitinib impurity 1 (CAS CATO-C4X-33081), a pharmacopoeial impurity reference standard (molecular formula C16H18N6O, MW 310.35 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Delgocitinib impurity 1 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 310.35 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Delgocitinib impurity 1 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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