Description

Montelukast Sulfoxide (Mixture Of Diastereomers) is a key pharmaceutical intermediate and metabolite of the leukotriene receptor antagonist Montelukast. This compound is critical for analytical research, method development, and quality control processes in pharmaceutical manufacturing. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical companies involved in the development and production of respiratory therapeutics. The material is supplied as a high-purity reference standard to support rigorous scientific and regulatory requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification and identification of Montelukast and its related substances in drug products and active pharmaceutical ingredients (APIs).
• Metabolite Studies: Used in pharmacokinetic and drug metabolism research to understand the biotransformation pathways of Montelukast.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for impurity profiling and assay determination.
• Quality Control & Assurance: Employed in in-house QC laboratories to monitor impurity levels, ensuring batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity standards for identification and qualification.

Basic Information

Item	Details
Product Name	Montelukast Sulfoxide (Mixture Of Diastereomers)
CAS No.	1152185-58-4
Molecular Formula	C35H36ClNO4S
Molecular Weight	602.18 g/mol
Synonyms	Montelukast Sulfoxide; Montelukast S-Oxide; 1-(((1-(R)-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid S-oxide; (R)-2-(1-((1-(3-(2-(7-Chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)sulfinyl)methyl)cyclopropyl)acetic acid; Montelukast EP Impurity G; Montelukast Sulfoxide Diastereomers
EINECS	Contact for details

Quality Control

Our Montelukast Sulfoxide (Mixture Of Diastereomers) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and diastereomer ratio confirmation, and is characterized by NMR and MS. A Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with cGMP principles for pharmaceutical intermediates and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 98.0% (Total of Diastereomers)
Diastereomer Ratio	Specified on COA
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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