Description

[2H6]-Enzalutamide is a deuterium-labeled analog of the non-steroidal antiandrogen drug Enzalutamide, specifically designed for use as an internal standard in quantitative bioanalytical studies. This stable isotope-labeled compound is essential for ensuring the accuracy and precision of mass spectrometry-based assays, providing critical data for pharmacokinetic and metabolic research. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in advanced drug development and clinical studies for prostate cancer therapeutics.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference compound in the quantitative analysis of Enzalutamide and its metabolites in biological matrices such as plasma, serum, and tissue homogenates.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Bioanalytical Method Development and Validation: Used to develop, optimize, and validate robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Provides reliable quantification of drug levels in patient samples during clinical trials for prostate cancer treatments.
• Metabolite Identification and Profiling: Aids in the structural elucidation and quantification of drug metabolites using high-resolution mass spectrometry.
• Quality Control in Pharmaceutical Manufacturing: Can be employed in process control and impurity profiling during the synthesis of Enzalutamide API.

Basic Information

Product Name	[2H6]-Enzalutamide
CAS No.	1443331-94-9
Molecular Formula	C21H10D6F4N4O2S
Molecular Weight	466.48 g/mol
Synonyms	Deuterated Enzalutamide; Enzalutamide-d6; 4-[3-[4-Cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl]-2-fluoro-N-methylbenzamide-d6; MDV3100-d6; Xtandi-d6 (labeled analog); Hexadeuterated Enzalutamide
EINECS	Contact for details

Quality Control

Our [2H6]-Enzalutamide is manufactured under strict quality systems to ensure the high purity and isotopic enrichment required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as chemical purity, isotopic purity (deuterium incorporation), and residual solvent content. We adhere to relevant industry standards for reference materials. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under an inert atmosphere for long-term stability. This compound is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 99.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH limits

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