Description

Zafirlukast is a selective and competitive leukotriene receptor antagonist (LTRA) that inhibits the action of cysteinyl leukotrienes. This compound is a critical active pharmaceutical ingredient (API) used in the formulation of anti-asthmatic medications. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for chronic asthma and related respiratory conditions.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral tablet formulations for the prophylaxis and chronic treatment of asthma.
• Respiratory Research: Used in biochemical and pharmacological studies to investigate leukotriene pathways and inflammatory responses in the lungs.
• Drug Development: Serves as a reference standard and key intermediate in the R&D of new anti-inflammatory and bronchodilator therapies.
• Generic Drug Manufacturing: Essential for companies producing generic versions of leukotriene receptor antagonist medications.
• Analytical Standard: Employed as a high-purity standard in quality control laboratories for HPLC, LC-MS, and other analytical methods.

Basic Information

Product Name	Zafirlukast
CAS No.	107753-78-6
Molecular Formula	C31H33N3O6S
Molecular Weight	575.68 g/mol
Synonyms	ICI 204,219; Accolate (Trade Name); Zafirlukastum; 4-(5-Cyclopentyloxycarbonylamino-1-methylindol-3-ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide; 3-(((1-(2-Hydroxy-2-propyl)-4-(4-(phenylmethyl)phenoxy)butyl)thio)methyl)benzoic acid (Related intermediate); Leukotriene D4 receptor antagonist; LTRA
EINECS	Contact for details

Quality Control

Our Zafirlukast is manufactured and tested to meet high-purity standards suitable for pharmaceutical applications. Quality assurance protocols are aligned with ICH guidelines and current Good Manufacturing Practices (cGMP). A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles as determined by validated analytical methods.

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 crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%

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