Montelukast Impurity 32 CAS 1187586-63-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1187586-63-5
Molecular FormulaC29H26ClNO
Molecular Weight439.98 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Montelukast Impurity 32 CAS 1187586-63-5 chemical structure

Description

Montelukast Impurity 32 (CAS 1187586-63-5) is a certified pharmaceutical impurity reference standard with the molecular formula C29H26ClNO and a molecular weight of 439.98 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Montelukast Impurity 32 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 439.98 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.

As a certified reference material (CRM), Montelukast Impurity 32 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

Molecular FormulaC29H26ClNO
Molecular Weight439.98 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)17.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1989
Halogen ContentCl-containing
Nitrogen Atoms1

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