Ramelteon Impurity 43 CAS 221530-42-3

Description

As a certified reference material (CRM), Ramelteon Impurity 43 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.

CATO supplies Ramelteon Impurity 43 (CAS 221530-42-3), a pharmacopoeial impurity reference standard (molecular formula C13H13NO2, MW 215.25 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, Ramelteon Impurity 43 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 215.25 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.

Physical & Chemical Properties

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