Description

Zileuton Related Compound A is a high-purity chemical reference standard, essential for pharmaceutical research and development. This compound serves as a critical impurity marker and analytical standard in the quality control of Zileuton, an active pharmaceutical ingredient used in asthma treatment. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and ensuring batch-to-batch consistency.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Zileuton active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Stability Studies: Employed as a benchmark to monitor the formation of related substances in Zileuton formulations under various stability-indicating conditions.
• Chemical Research: Serves as a key intermediate or building block in synthetic chemistry research for developing new leukotriene biosynthesis inhibitors.
• Quality Assurance/Quality Control (QA/QC): Integral for in-process testing and final release testing to ensure Zileuton API meets stringent pharmacopeial purity specifications.

Basic Information

Product Name	Zileuton Related Compound A
CAS No.	171370-49-3
Molecular Formula	C11H12N2O2S2
Molecular Weight	268.36 g/mol
Synonyms	N-Hydroxy-N-(1-benzo[b]thien-2-ylethyl)urea; 1-(1-Benzo[b]thien-2-ylethyl)-3-hydroxyurea; Zileuton Impurity A; Zileuton Related Substance A; ABT-007; Zileuton Hydroxyurea Metabolite; Zileuton EP Impurity A; Zileuton USP Related Compound A
EINECS	Contact for details

Quality Control

Our Zileuton Related Compound A is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability with a detailed Certificate of Analysis (COA) that includes batch number, expiration date, and results against relevant pharmacopeial standards (USP, EP). Our quality commitment ensures the reliability required for your most critical analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The compound is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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