Description

Zileuton (Sodium) is the sodium salt form of the selective 5-lipoxygenase inhibitor, zileuton. This compound is a critical active pharmaceutical ingredient (API) and a key intermediate in the synthesis of the final drug product. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of respiratory therapeutics. The material is supplied to meet the stringent quality requirements of the global pharmaceutical industry.

Application

• Active Pharmaceutical Ingredient (API): Primary use in the formulation of finished dosage forms for the treatment of asthma.
• Pharmaceutical Intermediate: Serves as a crucial synthetic precursor in the multi-step manufacturing process of zileuton-based medications.
• Reference Standard: Used in analytical laboratories for quality control, method development, and validation (HPLC, LC-MS).
• Biochemical Research: A tool compound for studying the 5-lipoxygenase pathway, leukotriene biosynthesis, and related inflammatory processes.
• Preclinical & Clinical Development: Employed in the R&D phase for new respiratory and anti-inflammatory drug candidates.
• Generic Drug Manufacturing: Essential for companies producing bioequivalent versions of branded zileuton medications.

Basic Information

Product Name	Zileuton (Sodium)
CAS No.	118569-21-4
Molecular Formula	C11H11N2O2Na
Molecular Weight	226.21 g/mol
Synonyms	N-Hydroxy-N-(1-benzo[b]thien-2-ylethyl)urea Sodium Salt; Zileuton Sodium; ABT-077; Zyflo CR (Salt Form); 1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea Sodium Salt; (±)-1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea Sodium Salt; A-64077 (Sodium Salt)
EINECS	Contact for details

Quality Control

Our Zileuton (Sodium) is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to ensure it meets high-purity standards suitable for pharmaceutical applications. A Certificate of Analysis (COA) detailing all test results against relevant specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white 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)	≤ 5.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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