Naltrexone Impurity 21 CAS 64643-76-1

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Naltrexone Impurity 21.

Naltrexone Impurity 21 (CAS 64643-76-1) is a certified pharmaceutical impurity reference standard with the molecular formula C21H23NO6 and a molecular weight of 385.41 g/mol.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Naltrexone Impurity 21 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 385.41 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

CATO manufactures Naltrexone Impurity 21 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

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