Montelukast Impurity 8 CAS CATO-C4X-10318

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-10318
Molecular FormulaC35H37ClNNaO3S
Molecular Weight610.18 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Montelukast Impurity 8 CAS CATO-C4X-10318 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Montelukast Impurity 8.

As a process- or degradation-related impurity, Montelukast Impurity 8 (CAS CATO-C4X-10318, C35H37ClNNaO3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a salt form, a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution, Montelukast Impurity 8 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 610.18 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

CATO manufactures Montelukast Impurity 8 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC35H37ClNNaO3S
Molecular Weight610.18 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)17.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1
Sulfur Atoms1

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