Description

Montelukast Bis-Sulfide (Mixture Of Diastereomers) is a key synthetic intermediate in the production of the leukotriene receptor antagonist, Montelukast Sodium. This compound is critical for pharmaceutical R&D and manufacturing, serving as a pivotal building block in the synthesis pathway. It is primarily utilized by active pharmaceutical ingredient (API) manufacturers and contract research organizations (CROs) focused on respiratory therapeutics.

Application

• Pharmaceutical Intermediate: Primary use as a crucial synthetic precursor in the multi-step synthesis of Montelukast Sodium API.
• Process Research & Development: Used in route scouting, optimization studies, and scale-up experiments for Montelukast production.
• Reference Standard: Serves as an analytical standard for method development and quality control during API manufacturing.
• Impurity Profiling: Employed in the identification and quantification of related substances in final drug substance batches.
• Academic Research: Utilized in medicinal chemistry studies exploring structure-activity relationships of cysteinyl leukotriene receptor antagonists.

Basic Information

Product Name	Montelukast Bis-Sulfide (Mixture Of Diastereomers)
CAS No.	1187586-61-3
Molecular Formula	C35H36ClNO3S2
Molecular Weight	618.24 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, sulfide derivative; Montelukast sulfide intermediate; Montelukast disulfide analog; (R)-2-(1-((1-(3-(2-(7-Chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)thio)methyl)cyclopropyl)acetic acid sulfide; SQ-31,491 bis-sulfide; MK-0476 intermediate (bis-sulfide form)
EINECS	Contact for details

Quality Control

Our Montelukast Bis-Sulfide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and diastereomeric ratio, and is supported by a detailed Certificate of Analysis (COA). We ensure compliance with ICH guidelines for impurities and can supply material suitable for use in GMP-regulated environments upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). Keep the container in a dry, well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Diastereomeric Ratio (HPLC)	Specified per batch
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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