Alectinib impurity 20 CAS 2287185-55-9

Description

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

CATO supplies Alectinib impurity 20 (CAS 2287185-55-9), a pharmacopoeial impurity reference standard (molecular formula C25H27IN2O5, MW 562.40 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution, Alectinib impurity 20 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 562.40 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Alectinib 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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