Ezetimibe Impurity 105 CAS 1296129-16-2

Description

The occurrence of Ezetimibe Impurity 105 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Ezetimibe Impurity 105 (CAS 1296129-16-2) is a certified pharmaceutical impurity reference standard with the molecular formula C33H30F2N2O5 and a molecular weight of 572.60 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Ezetimibe Impurity 105 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 572.60 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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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