Valsartan Impurity 13 ( Valproic Acid EP Impurity A ) CAS 109-52-4

Description

The occurrence of Valsartan Impurity 13 ( Valproic Acid EP Impurity A ) is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Valsartan Impurity 13 ( Valproic Acid EP Impurity A ) (CAS 109-52-4), a pharmacopoeial impurity reference standard (molecular formula C5H10O2, MW 102.13 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Valsartan Impurity 13 ( Valproic Acid EP Impurity A ) (C5H10O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 1.0, corresponding to approximately 1 ring(s) or double-bond equivalent(s). With a molecular weight of 102.13 g/mol, it falls into the low-molecular-weight range.

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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