Description

Montelukast CAS NO 158966-92-8 is a potent and selective leukotriene receptor antagonist (LTRA) that plays a critical role in managing inflammatory pathways. This active pharmaceutical ingredient (API) is essential for the formulation of medications targeting respiratory conditions. It is primarily required by pharmaceutical manufacturers and research institutions engaged in developing treatments for asthma and allergic rhinitis.

Application

• Pharmaceutical API: Core active ingredient in prescription medications for the prophylaxis and chronic treatment of asthma.
• Allergy Management: Used in formulations to relieve symptoms of seasonal allergic rhinitis (hay fever).
• Drug Development: Serves as a reference standard and key intermediate in R&D for new anti-inflammatory therapeutics.
• Generic Drug Manufacturing: Critical for producing cost-effective generic versions of leukotriene modifier drugs.
• Clinical Research: Utilized in studies investigating leukotriene pathways and related inflammatory disorders.
• Veterinary Pharmaceuticals: Potential application in developing treatments for respiratory conditions in animals.

Basic Information

Product Name	Montelukast
CAS No.	158966-92-8
Molecular Formula	C35H36ClNO3S
Molecular Weight	586.19 g/mol
Synonyms	Montelukast Sodium; MK-0476; L-706,631; (±)-1-[[[(1R)-1-[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid; Singulair (Brand Name); Leukotriene D4 receptor antagonist; Montelukast acid
EINECS	Contact for details

Quality Control

Our Montelukast is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for assay and related substances, residual solvent analysis, and identification by IR and NMR, to ensure it meets high-purity standards suitable for pharmaceutical use. Certificates of Analysis (COA) compliant with current pharmacopeial requirements (USP/EP) are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water (KF)	NMT 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.2%

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