Naltrexone EP Impurity H CAS 503090-99-1

Description

Compared with other compounds in its class, the molecular weight of 343.42 g/mol gives Naltrexone EP Impurity H distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Naltrexone EP Impurity H (CAS 503090-99-1), a pharmacopoeial impurity reference standard (molecular formula C20H25NO4, MW 343.42 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, Naltrexone EP Impurity H is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 343.42 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), Naltrexone EP Impurity H 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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