Description

Zileuton-D4 (Major) is a deuterated isotopologue of the leukotriene biosynthesis inhibitor Zileuton, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity compound is essential for ensuring accuracy and reliability in mass spectrometry-based assays, particularly in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical research and development laboratories, contract research organizations (CROs), and analytical service providers requiring definitive quantification of Zileuton.

Application

• Primary use as an Internal Standard (IS) for the quantification of Zileuton in biological matrices (e.g., plasma, serum, urine) via LC-MS/MS and GC-MS.
• Supporting Bioanalytical Method Development and Validation for clinical and preclinical studies of Zileuton.
• Application in Drug Metabolism and Pharmacokinetics (DMPK) research to study the absorption, distribution, metabolism, and excretion (ADME) profile of Zileuton.
• Use in Stability-Indicating Assays and impurity profiling to monitor drug substance and product quality.
• Critical component in Regulatory Submissions to agencies like the FDA and EMA, where validated analytical methods with stable isotope-labeled standards are required.
• Research into the Mechanism of Action and biochemical pathways involving 5-lipoxygenase inhibition.

Basic Information

Product Name	Zileuton-D4 (Major)
CAS No.	1189878-76-9
Molecular Formula	C11H8D4N2O2S
Molecular Weight	238.31 g/mol (approx.)
Synonyms	N-Hydroxy-N-(1-benzo[b]thien-2-ylethyl-D4)urea; Zileuton (phenyl-D4); Zileuton-d4; ABT-077-D4; A-64077-D4; Leutrol-D4; 1-(1-Benzo[b]thien-2-ylethyl-D4)-1-hydroxyurea; [D4]-Zileuton
EINECS	Contact for details

Quality Control

Every batch of Zileuton-D4 (Major) is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, with comprehensive characterization using NMR (¹H, ¹³C), Mass Spectrometry, and HPLC. A Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity (HPLC assay), isotopic enrichment (D-content), and residual solvents. Our quality commitment supports compliance with cGMP and ICH guidelines for materials intended for use in regulated bioanalysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant and inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0% (Area %)
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity (¹H NMR)	Consistent with structure
Residual Solvents (GC)	Meets ICH limits
Water Content (KF)	≤ 0.5% w/w

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