Montelukast EP Impurity C(Mixture of Diastereomers) CAS 909849-96-3

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Montelukast EP Impurity C(Mixture of Diastereomers).

CATO supplies Montelukast EP Impurity C(Mixture of Diastereomers) (CAS 909849-96-3), a pharmacopoeial impurity reference standard (molecular formula C35H36ClNO4S, MW 602.18 g/mol) used for the identification and quantification of trace impurities in APIs.

Montelukast EP Impurity C(Mixture of Diastereomers) (C35H36ClNO4S) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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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