Raltegravir EP Impurity B CAS 1193687-85-2

Description

The occurrence of Raltegravir EP Impurity B is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Raltegravir EP Impurity B (CAS 1193687-85-2), a pharmacopoeial impurity reference standard (molecular formula C19H24FN5O3, MW 389.42 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, fluorine substitution, Raltegravir EP Impurity B is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 389.42 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.

As a certified reference material (CRM), Raltegravir EP Impurity B 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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