Montelukast EP Impurity A(Sodium Salt) CAS 190078-45-6

Description

Compared with other compounds in its class, the molecular weight of 608.17 g/mol gives Montelukast EP Impurity A(Sodium Salt) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Montelukast EP Impurity A(Sodium Salt) (CAS 190078-45-6), a pharmacopoeial impurity reference standard (molecular formula C35H35ClNO3SNa, MW 608.17 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a salt form, a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution, Montelukast EP Impurity A(Sodium Salt) is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 608.17 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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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