Description

Montelukast Sodium is the active pharmaceutical ingredient (API) of the leukotriene receptor antagonist class, widely used in the treatment of asthma and allergic rhinitis. Its primary value lies in its selective and competitive antagonism of the cysteinyl leukotriene type 1 receptor, effectively preventing bronchoconstriction and inflammation. This high-purity compound is essential for pharmaceutical manufacturers developing and producing finished dosage forms, such as tablets and chewable tablets, for global respiratory therapeutics markets.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for the prophylaxis and chronic treatment of asthma.
• Antiasthmatic Formulations: Key component in chewable and film-coated tablet formulations designed for both adult and pediatric patients.
• Allergic Rhinitis Treatment: Used in medications for the relief of symptoms of seasonal and perennial allergic rhinitis.
• Respiratory Research: Serves as a critical reference standard and biochemical tool in pharmacological research targeting leukotriene pathways.
• Generic Drug Manufacturing: A vital raw material for companies producing bioequivalent generic versions of branded montelukast medications.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for clinical trial material and commercial production.

Basic Information

Product Name	Montelukast Sodium
CAS No.	162515-69-7
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); Leukotriene D4 receptor antagonist; LTD4 antagonist; (R)-Montelukast Sodium
EINECS	Contact for details

Quality Control

Our Montelukast Sodium is manufactured under strict quality management systems. It is typically tested to meet or exceed relevant pharmacopeial standards such as USP and EP monographs. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, detailing purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

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)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	-165° to -175° (c=1 in methanol)

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