Description

Montelukast is a potent and selective leukotriene receptor antagonist (LTRA) used primarily as an active pharmaceutical ingredient (API). This compound is critical for the formulation of medications that provide prophylactic and chronic treatment for asthma and allergic rhinitis. It is essential for pharmaceutical manufacturers engaged in the production of anti-inflammatory and anti-allergy therapeutics, ensuring consistent quality and reliable supply for global healthcare needs.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for asthma management.
• Anti-allergy Formulations: Key component in drugs targeting symptoms of allergic rhinitis (hay fever).
• Pediatric & Adult Dosage Forms: Used in the manufacture of chewable tablets, oral granules, and standard film-coated tablets.
• Respiratory Disease Research: Serves as a reference standard and biochemical tool in pharmacological R&D for leukotriene pathways.
• Generic Drug Production: Critical for manufacturers developing bioequivalent versions of branded leukotriene modifier drugs.
• Combination Therapies: Potential for use in fixed-dose combination products for enhanced respiratory treatment.

Basic Information

Product Name	Montelukast
CAS No.	158916-92-8
Molecular Formula	C35H36ClNO3S
Molecular Weight	586.19 g/mol
Synonyms	Montelukast Sodium; MK-0476; Singulair® (Brand Name); 1-(((1-(R)-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid; Leukotriene D4 receptor antagonist; LTRA; (R)-Montelukast
EINECS	Contact for details

Quality Control

Our Montelukast is manufactured under strict quality systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Each batch undergoes comprehensive analytical testing including identity, purity, and impurity profile determination. A Certificate of Analysis (COA) documenting all test results is provided to ensure full traceability and compliance for our pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 Titration)	NMT 5.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm

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