Description

Montelukast Sulfoxide (Mixture Of Diastereomers) is a key pharmaceutical intermediate and impurity standard critical for quality control in drug manufacturing. This compound is essential for research and development, particularly in the study of drug metabolism and the synthesis of active pharmaceutical ingredients (APIs). It is primarily needed by pharmaceutical companies, analytical laboratories, and research institutions focused on respiratory therapeutics and analytical method development.

Application

• Pharmaceutical Intermediate: Used in the synthesis and research of leukotriene receptor antagonists for asthma and allergy treatments.
• Reference Standard: Serves as a critical impurity standard for HPLC and LC-MS analysis in the quality control of Montelukast Sodium API and finished drug products.
• Metabolite Studies: Employed in pharmacokinetic and drug metabolism research to understand the oxidation pathway of Montelukast.
• Analytical Method Development: Essential for developing and validating stability-indicating methods for related substance testing.
• Process Chemistry: Used in the investigation and optimization of API manufacturing processes to control and quantify sulfoxide impurities.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity material for identification and qualification studies.

Basic Information

Product Name	Montelukast Sulfoxide (Mixture Of Diastereomers)
CAS No.	909849-96-3
Molecular Formula	C35H36ClNO4S
Molecular Weight	602.18 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 S-oxide; Montelukast Sulfoxide Diastereomers; Montelukast Related Compound H (Sulfoxide); (R,E)-2-(1-((1-(3-(2-(7-Chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)thio)methyl)cyclopropyl)acetic acid S-oxide
EINECS	Contact for details

Quality Control

Our Montelukast Sulfoxide (Mixture Of Diastereomers) is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and diastereomer ratio, NMR, and MS for structural confirmation, to ensure it meets the high standards required for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label/certificate of analysis. This material is light-sensitive and easily oxidized; for long-term storage, consider under an inert atmosphere (e.g., nitrogen or argon) in a freezer (-20°C). Keep the container tightly sealed in a dry and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Diastereomer Ratio (HPLC)	Specified per batch
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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