Trandolapril Impurity 7 CAS CATO-C4X-17707

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Trandolapril Impurity 7.

CATO supplies Trandolapril Impurity 7 (CAS CATO-C4X-17707), a pharmacopoeial impurity reference standard (molecular formula C16H21NO2, MW 259.34 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, Trandolapril Impurity 7 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 259.34 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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