Montelukast Impurity N1 CAS 162489-70-5

Description

Compared with other compounds in its class, the molecular weight of 588.20 g/mol gives Montelukast Impurity N1 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Montelukast Impurity N1 (CAS 162489-70-5), a pharmacopoeial impurity reference standard (molecular formula C35H38ClNO3S, MW 588.20 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution, Montelukast Impurity N1 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

As a certified reference material (CRM), Montelukast Impurity N1 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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