Description

Montelukast Sodium is the sodium salt of a potent and selective leukotriene receptor antagonist, primarily used as the active pharmaceutical ingredient (API) in anti-asthma and allergy medications. Its core value lies in its ability to block substances in the body that cause inflammation, bronchoconstriction, and mucus production, providing critical therapeutic relief. This high-purity compound is essential for pharmaceutical manufacturers developing and producing prescription drugs for the treatment of chronic asthma and seasonal allergic rhinitis.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in anti-asthma medications.
• Formulation of prescription drugs for the prophylaxis and chronic treatment of asthma in adults and pediatric patients.
• Manufacturing of pharmaceutical products for the relief of symptoms of seasonal allergic rhinitis (hay fever).
• Key component in the production of chewable tablets, film-coated tablets, and oral granules.
• Used in research and development of new leukotriene-modifying therapies.
• Reference standard material for analytical testing and quality control in pharmaceutical laboratories.

Basic Information

Product Name	Montelukast Sodium
CAS No.	1187586-63-5
Molecular Formula	C35H35ClNNaO3S
Molecular Weight	608.17 g/mol
Synonyms	Montelukast Na; MK-0476; Sodium 2-[1-[(1R)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]sulfanylmethyl]cyclopropylacetate; 1-[[[(1R)-1-[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid sodium salt; Singulair (Trade Name)
EINECS	Contact for details

Quality Control

Our Montelukast Sodium is manufactured under strict quality systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Each batch undergoes rigorous analytical testing including identification, assay, impurity profiling, and residual solvent analysis to ensure it meets the stringent requirements for pharmaceutical actives. A comprehensive Certificate of Analysis (COA) documenting purity, related substances, and other critical parameters is provided with every shipment.

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. For long-term storage, consider desiccated conditions.

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 unknown: ≤ 0.10% Total Impurities: ≤ 1.0%
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.