Description

Acenocoumarol-D4 is a stable isotope-labeled analog of the anticoagulant drug acenocoumarol, specifically deuterated at four positions. This high-purity reference standard is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities for applications in drug metabolism and pharmacokinetics (DMPK) studies, clinical trials, and quality control.

Application

• Internal Standard for LC-MS/MS: Serves as a critical internal standard for the precise quantification of acenocoumarol and its metabolites in complex biological matrices like plasma, serum, and urine.
• Drug Metabolism Studies (DMPK): Used in pharmacokinetic (PK) and pharmacodynamic (PD) research to track the absorption, distribution, metabolism, and excretion (ADME) profile of the parent drug.
• Clinical Trial Analysis: Enables accurate therapeutic drug monitoring (TDM) and bioequivalence studies during clinical development phases.
• Forensic and Anti-Doping Analysis: Supports the detection and confirmation of acenocoumarol in forensic toxicology and sports anti-doping control programs.
• Method Development and Validation: A key component in developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Quality Control & Regulatory Compliance: Used in pharmaceutical QC labs to ensure batch-to-batch consistency and to meet stringent regulatory submission requirements for new drug applications.

Basic Information

Product Name	Acenocoumarol-D4
CAS No.	1185071-64-0
Molecular Formula	C19H11D4NO6
Molecular Weight	357.35 g/mol (approx.)
Synonyms	Acenocoumarol-d4; 4-Hydroxy-3-[1-(4-nitrophenyl)-3-oxobutyl]-2H-1-benzopyran-2-one-d4; Nicoumalone-d4; Sintrom-d4; Syncumar-d4; 3-(α-Acetonyl-4-nitrobenzyl)-4-hydroxycoumarin-d4; 3-[2-Acetyl-1-(4-nitrophenyl)ethyl]-4-hydroxy-2H-chromen-2-one-d4
EINECS	Contact for details

Quality Control

Every batch of Acenocoumarol-D4 is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) detailing isotopic purity, chemical purity, and identity confirmation. Our quality protocols are designed to meet the exacting standards required for pharmaceutical reference materials, supporting compliance with ICH Q2(R1) guidelines for analytical method validation.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (NMR/MS)	≥98.0 atom % D
Chemical Purity (HPLC)	≥95.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤1.0%

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