Description

Montelukast Sulfone CAS NO 1266620-74-9 is a key pharmaceutical intermediate and reference standard, primarily known for its role in the synthesis and quality control of the active pharmaceutical ingredient Montelukast Sodium. This compound is critical for ensuring the purity, safety, and efficacy of finished drug products. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on developing and producing respiratory therapeutics, particularly leukotriene receptor antagonists.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of Montelukast Sodium, the active ingredient in asthma and allergy medications.
• Analytical Reference Standard: Used in High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS), and other analytical methods for the identification, assay, and impurity profiling of Montelukast Sodium.
• Process Development & Validation: Employed in research and development to optimize manufacturing processes, establish control strategies, and validate analytical methods according to ICH guidelines.
• Quality Control & Assurance: Serves as a system suitability standard and a known impurity marker to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., USP, EP).
• Metabolite and Degradation Studies: Utilized in research to study the metabolic pathways and stability profiles of Montelukast, aiding in drug safety and formulation development.
• Regulatory Submissions: Provides essential data and characterization for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).

Basic Information

Product Name	Montelukast Sulfone
CAS No.	1266620-74-9
Molecular Formula	C35H35ClNO4S
Molecular Weight	601.17 g/mol
Synonyms	1-(((1-(R)-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid sulfone; Montelukast Sulfone Impurity; Montelukast EP Impurity G; Montelukast Sulfoxide Related Compound; SQ 31,636 Sulfone; MK-0476 Sulfone
EINECS	Contact for details

Quality Control

Our Montelukast Sulfone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis to ensure it meets stringent standards for pharmaceutical intermediates and reference materials. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.5%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.