Glutamic acid Impurity 11 CAS CATO-C4X-286211

Description

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 supplies Glutamic acid Impurity 11 (CAS CATO-C4X-286211), a pharmacopoeial impurity reference standard (molecular formula C142H214N38O44, MW 3157.45 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C142H214N38O44, Glutamic acid Impurity 11 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 3157.45 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).

As a certified reference material (CRM), Glutamic acid Impurity 11 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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