Montelukast Impurity 50 CAS 1044705-96-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1044705-96-5
Molecular FormulaC37H40ClNO3S
Molecular Weight614.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Montelukast Impurity 50 CAS 1044705-96-5 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 614.24 g/mol gives Montelukast Impurity 50 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Montelukast Impurity 50 (CAS 1044705-96-5) is a certified pharmaceutical impurity reference standard with the molecular formula C37H40ClNO3S and a molecular weight of 614.24 g/mol.

The molecular framework of Montelukast Impurity 50 (C37H40ClNO3S) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

As a certified reference material (CRM), Montelukast Impurity 50 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 FormulaC37H40ClNO3S
Molecular Weight614.24 g/mol
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1988
Halogen ContentCl-containing
Nitrogen Atoms1
Sulfur Atoms1

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