Description

Montelukast is a potent and selective leukotriene receptor antagonist (LTRA) used to manage respiratory conditions. This active pharmaceutical ingredient (API) is critical for the formulation of medications that provide long-term control and prophylaxis of asthma and allergic rhinitis. It is essential for pharmaceutical manufacturers and R&D institutions focused on developing and producing anti-asthmatic and anti-allergy therapeutics. The compound is supplied as a high-purity material suitable for formulation into final dosage forms.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for asthma and seasonal allergies.
• Tablet Formulation: Used in the manufacture of chewable and film-coated tablets for oral administration.
• Granule Production: Key component in oral granule formulations, often used for pediatric patients.
• Anti-asthmatic Drugs: Core component in maintenance treatment regimens for chronic asthma to prevent bronchoconstriction.
• Allergic Rhinitis Treatment: Used in medications for the relief of symptoms associated with perennial and seasonal allergic rhinitis.
• Research & Development: Serves as a reference standard and starting material in pharmacological research and new drug development.
• Generic Drug Manufacturing: Critical for companies producing bioequivalent versions of branded leukotriene modifier drugs.

Basic Information

Product Name	Montelukast
CAS No.	142522-28-9
Molecular Formula	C35H36ClNO3S
Molecular Weight	586.19 g/mol
Synonyms	Montelukast Sodium; MK-0476; Singulair; 1-(((1-(R)-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid; (+)-(S)-4-(4-(4-Chlorophenyl)-4-hydroxy-1-piperidyl)-1-(4-fluorophenyl)butan-1-one; Leukotriene D4 receptor antagonist; LTRA
EINECS	Contact for details

Quality Control

Our Montelukast is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use. Certificates of Analysis (COA) are provided with each batch, detailing parameters such as assay, related substances, and residual solvents. We can support compliance with relevant pharmacopoeial standards (e.g., USP, EP) 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. For long-term storage, consider using desiccants.

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)	Total impurities: NMT 2.0% Any individual impurity: NMT 0.5%
Water Content (KF)	NMT 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm

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