Montelukast Impurity 21 CAS 142147-67-9

Description

The occurrence of Montelukast Impurity 21 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Montelukast Impurity 21 (CAS 142147-67-9) is a certified pharmaceutical impurity reference standard with the molecular formula C35H38ClNO3S and a molecular weight of 588.20 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution, Montelukast Impurity 21 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 588.20 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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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