Description

Methyl-Benzoate,Zafirlukast is a synthetic leukotriene receptor antagonist (LTRA) used as a key active pharmaceutical ingredient (API). Its primary value lies in its targeted mechanism of action for managing chronic respiratory conditions. This compound is essential for pharmaceutical manufacturers developing formulations for asthma prophylaxis and treatment. The product is supplied under stringent quality control to meet the exacting standards of the global pharmaceutical industry.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral tablet formulations for the prevention and chronic treatment of asthma.
• Respiratory Therapeutics: Specifically indicated for managing symptoms associated with bronchoconstriction and airway inflammation.
• Drug Development: Serves as a critical reference standard and raw material in R&D for new respiratory disease therapies.
• Generic Drug Manufacturing: Used in the production of bioequivalent generic versions of leukotriene receptor antagonist medications.
• Clinical Research: Employed in pharmacological studies and clinical trials investigating leukotriene pathways.

Basic Information

Item	Details
Product Name	Methyl-Benzoate,Zafarlukast
CAS No.	107754-15-4
Molecular Formula	C31H33N3O6S
Molecular Weight	575.68 g/mol
Synonyms	Zafirlukast; ICI-204,219; Accolate (Trade Name); Benzenepropanoic acid, 4-[[(1R)-1-[[[3-[(4-acetyl-3-hydroxy-2-propylphenoxy)methyl]phenyl]amino]carbonyl]ethyl]thio]methyl]-γ-oxo-, methyl ester; 4-[[(1R)-1-[[[3-[(4-Acetyl-3-hydroxy-2-propylphenoxy)methyl]phenyl]amino]carbonyl]ethyl]thio]methyl]-γ-oxobenzenebutanoic acid methyl ester; Methyl 4-[[(1R)-1-[[[3-[(4-acetyl-3-hydroxy-2-propylphenoxy)methyl]phenyl]amino]carbonyl]ethyl]thio]methyl]-γ-oxobenzenebutanoate
EINECS	Contact for details

Quality Control

Our Zafirlukast API is manufactured under current Good Manufacturing Practice (cGMP) conditions, ensuring compliance with major pharmacopoeial standards such as USP and ICH Q7 guidelines. Every batch undergoes rigorous analytical testing including HPLC for purity, residual solvent analysis, and identification. A comprehensive Certificate of Analysis (COA) detailing all specifications and results is provided with each 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.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 1.0%
Related Substances (HPLC)	Total impurities: NMT 2.0% Any individual impurity: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.2%

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