Montelukast Sodium EP Impurity G CAS 1428448-96-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1428448-96-7
Molecular FormulaC35H35ClNNaO3S
Molecular Weight608.17 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Montelukast Sodium EP Impurity G CAS 1428448-96-7 chemical structure

Description

Structurally, Montelukast Sodium EP Impurity G (C35H35ClNNaO3S) contains a salt form, a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 18.5, corresponding to approximately 18 ring(s) or double-bond equivalent(s). With a molecular weight of 608.17 g/mol, it falls into the high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

As a process- or degradation-related impurity, Montelukast Sodium EP Impurity G (CAS 1428448-96-7, C35H35ClNNaO3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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

Molecular FormulaC35H35ClNNaO3S
Molecular Weight608.17 g/mol
Purity>95%
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)18.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentCl-containing
Nitrogen Atoms1
Sulfur Atoms1

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