Irbesartan Impurity 11 CAS 1346598-52-4

Description

The occurrence of Irbesartan Impurity 11 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Irbesartan Impurity 11 (CAS 1346598-52-4) is a certified pharmaceutical impurity reference standard with the molecular formula C39H38N10O and a molecular weight of 662.79 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Irbesartan Impurity 11 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 662.79 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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