Description

Zileuton is a potent and selective inhibitor of the 5-lipoxygenase (5-LOX) enzyme, a key regulator in the leukotriene synthesis pathway. This mechanism of action makes it a critical active pharmaceutical ingredient (API) for the development of anti-inflammatory and anti-asthmatic therapeutics. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in drug development, formulation, and clinical studies targeting respiratory and inflammatory conditions.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for the treatment and management of chronic asthma.
• Research & Development: A vital biochemical tool for studying the 5-lipoxygenase pathway, leukotriene biology, and related inflammatory processes in preclinical research.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in pharmaceutical laboratories.
• Formulation Development: Used in the development of various dosage forms, including immediate-release and controlled-release tablets.
• Clinical Trial Material (CTM): Supplied under GMP conditions for use in Phase I-III clinical trials for new respiratory and anti-inflammatory drug candidates.

Basic Information

Product Name	Zileuton
CAS No.	111406-87-2
Molecular Formula	C11H12N2O2S
Molecular Weight	236.29 g/mol
Synonyms	N-(1-Benzo[b]thien-2-ylethyl)-N-hydroxyurea; ABT-077; Leutrol; Zyflo; Zyflo CR; A-64077; (±)-Zileuton; 1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea
EINECS	Contact for details

Quality Control

Our Zileuton is manufactured and tested to meet stringent pharmaceutical-grade specifications. Quality assurance protocols align with current Good Manufacturing Practices (cGMP) and include comprehensive analytical testing for identity, purity, and potency. A detailed Certificate of Analysis (COA) is provided with each batch, confirming compliance with agreed-upon specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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