Description

Montelukast Sodium is a selective leukotriene receptor antagonist (LTRA) used as the active pharmaceutical ingredient (API) in the formulation of anti-asthmatic and anti-allergic medications. Its primary value lies in its proven efficacy for the prophylaxis and chronic treatment of asthma, as well as the relief of symptoms of allergic rhinitis. This high-purity compound is essential for pharmaceutical manufacturers and research institutions developing and producing solid oral dosage forms, such as tablets and chewable tablets, targeting respiratory conditions.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for asthma and allergies.
• Tablet Formulation: Direct compression or granulation processes for standard and chewable tablet production.
• Granule & Sachet Production: For pediatric or alternative oral solid dosage forms.
• Clinical Research: Used in preclinical and clinical studies for respiratory and inflammatory diseases.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control laboratories.
• Drug Development: A key intermediate in the R&D of new leukotriene-modifying therapies.

Basic Information

Product Name	Montelukast Sodium
CAS No.	120578-04-3
Molecular Formula	C35H35ClNNaO3S
Molecular Weight	608.17 g/mol
Synonyms	Montelukast Sodium Salt; 1-(((1-(R)-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid sodium salt; MK-0476; Singulair® (Brand Name API); Sodium montelukast; (R)-Montelukast sodium; Leukotriene D4 receptor antagonist
EINECS	Contact for details

Quality Control

Our Montelukast Sodium is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing for identity, purity, and impurities. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological quality is provided to ensure full traceability and compliance with cGMP guidelines for pharmaceutical ingredients.

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 dry environment to prevent degradation. The original container should be kept tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with EP/USP

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