Description

Montelukast Sodium is the sodium salt of a potent and selective leukotriene receptor antagonist. This active pharmaceutical ingredient (API) is critical for the formulation of anti-asthmatic and anti-allergic medications, providing targeted therapeutic action. It is primarily required by pharmaceutical manufacturers for the production of oral solid dosage forms, such as tablets and chewable tablets, to treat conditions like asthma and allergic rhinitis.

Application

• Primary Active Pharmaceutical Ingredient (API) in anti-asthma medications.
• Key component in the manufacture of oral tablets and chewable tablets for pediatric and adult use.
• Used in the treatment and prophylaxis of chronic asthma.
• Applied in therapy for the relief of symptoms of seasonal allergic rhinitis (hay fever).
• Utilized in pharmaceutical research and development for new drug formulations.
• Essential for generic drug manufacturers producing leukotriene receptor antagonist therapies.

Basic Information

Product Name	Montelukast Sodium
CAS No.	151767-02-1
Molecular Formula	C35H35ClNNaO3S
Molecular Weight	608.17 g/mol
Synonyms	Montelukast Na; 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); Sodium (2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)sulfanyl)methyl)cyclopropyl)acetate
EINECS	Contact for details

Quality Control

Our Montelukast Sodium is manufactured under strict quality systems. It undergoes rigorous analytical testing to ensure compliance with pharmaceutical-grade standards, including identity, purity, and impurity profile assessments. Certificates of Analysis (COA) documenting compliance with relevant specifications are available upon request.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time matches reference
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

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