Allisartan Isoproxil Impurity 10 CAS CATO-C4X-321710

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Allisartan Isoproxil Impurity 10.

CATO supplies Allisartan Isoproxil Impurity 10 (CAS CATO-C4X-321710), a pharmacopoeial impurity reference standard (molecular formula C41H35ClN6O2, MW 679.21 g/mol) used for the identification and quantification of trace impurities in APIs.

Allisartan Isoproxil Impurity 10 (C41H35ClN6O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Allisartan Isoproxil Impurity 10 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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