Description

Montelukast Sodium CAS NO 30220-25-8 is a selective and orally active leukotriene receptor antagonist. This compound is of critical importance as the active pharmaceutical ingredient (API) in medications used to manage chronic respiratory conditions. It is primarily required by pharmaceutical manufacturers for the production of prescription drugs targeting asthma and allergic rhinitis.

Application

• Pharmaceutical API: Primary use as the active ingredient in anti-asthma and anti-allergy medications.
• Tablet Formulation: Used in the manufacture of chewable and film-coated tablets for oral administration.
• Granule Production: Key component in the formulation of oral granules, particularly for pediatric use.
• Respiratory Therapeutics: Essential for drugs providing prophylaxis and chronic treatment of asthma.
• Allergy Management: Foundational component in medications for the relief of symptoms of allergic rhinitis (seasonal and perennial).
• Prevention of Exercise-Induced Bronchoconstriction: Used in formulations intended to prevent airway constriction caused by physical exertion.
• Research & Development: Serves as a reference standard and key intermediate in pharmacological research focused on leukotriene pathways.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for generic and branded drug production.

Basic Information

Product Name	Montelukast Sodium
CAS No.	30220-25-8
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; [R-(E)]-1-[[[1-[3-[2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetate; (R)-Montelukast Sodium; Leukotriene D4 Receptor Antagonist
EINECS	Contact for details

Quality Control

Our Montelukast Sodium is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical use. We adhere to relevant pharmacopeial monographs (USP, EP) and GMP (Good Manufacturing Practice) guidelines. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with each batch to ensure full traceability and compliance.

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 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%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Specific Rotation	+58° to +62° (c=1 in methanol)

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