Description

Zileuton Impurity 2 is a specified impurity of the active pharmaceutical ingredient Zileuton, a 5-lipoxygenase inhibitor used in the treatment of asthma. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories for ensuring the purity, safety, and regulatory compliance of Zileuton-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Zileuton active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Critical for preparing impurity identification and qualification reports required for drug master files (DMFs), ANDAs, and INDs submitted to agencies like the FDA and EMA.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Aids in optimizing synthetic routes and purification processes to minimize the formation of this impurity during Zileuton manufacturing.

Basic Information

Product Name	Zileuton Impurity 2
CAS No.	1026256-93-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zileuton Related Compound 2; Zileuton Impurity B; Zileuton EP Impurity B; Zileuton USP Related Compound; N-Hydroxy-N-(1-benzo[b]thien-2-ylethyl)urea (related structure); ABT-761 Impurity; 5-Lipoxygenase Inhibitor Impurity; Leukotriene Synthesis Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Zileuton Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing batch-specific results, and is available upon request. Our quality commitment aligns with cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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