Montelukast Impurity 27 CAS 168214-67-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.168214-67-3
Molecular FormulaC29H26ClNO
Molecular Weight439.98 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Montelukast Impurity 27 CAS 168214-67-3 chemical structure

Description

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.

CATO supplies Montelukast Impurity 27 (CAS 168214-67-3), a pharmacopoeial impurity reference standard (molecular formula C29H26ClNO, MW 439.98 g/mol) used for the identification and quantification of trace impurities in APIs.

Montelukast Impurity 27 (C29H26ClNO) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

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.)2005
Halogen ContentCl-containing
Nitrogen Atoms1

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