Ibrutinib Impurity 109 CAS 2803461-05-2

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ibrutinib Impurity 109.

CATO supplies Ibrutinib Impurity 109 (CAS 2803461-05-2), a pharmacopoeial impurity reference standard (molecular formula C20H19N5O, MW 345.40 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Ibrutinib Impurity 109 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 345.40 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), Ibrutinib Impurity 109 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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