Description

Nilutamide-D6 is a deuterated analog of the non-steroidal anti-androgen drug nilutamide, specifically designed for use as an internal standard in analytical chemistry. This high-purity stable isotope-labeled compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry analyses. It is primarily utilized by pharmaceutical researchers, contract research organizations (CROs), and analytical laboratories engaged in drug metabolism and pharmacokinetics (DMPK) studies, bioanalytical method development, and quality control testing.

Application

• Internal Standard for LC-MS/MS: Serves as a critical internal standard for the precise quantification of nilutamide and its metabolites in complex biological matrices such as plasma, serum, and urine.
• Drug Metabolism Studies (DMPK): Used in pharmacokinetic and pharmacodynamic research to track drug absorption, distribution, metabolism, and excretion (ADME) with high specificity.
• Bioanalytical Method Development: Enables the development and validation of robust, sensitive, and selective analytical methods in compliance with GLP and FDA guidelines.
• Clinical Research: Supports therapeutic drug monitoring and clinical trial sample analysis for prostate cancer treatments involving anti-androgen therapies.
• Pharmaceutical Quality Control: Facilitates impurity profiling and assay verification of nilutamide in active pharmaceutical ingredient (API) and finished drug product batches.
• Forensic and Toxicological Analysis: Aids in the accurate detection and quantification of nilutamide in forensic toxicology screenings.

Basic Information

Product Name	Nilutamide-D6
CAS No.	1189477-66-4
Molecular Formula	C12H4D6F3N3O4
Molecular Weight	320.23 g/mol
Synonyms	5,5-Dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione-d6; RU 23908-d6; Anandron-d6; Nilutamide (hexadeuterated); Nilutamide-d6 Internal Standard; [2H6]-Nilutamide; Deuterated Nilutamide
EINECS	Contact for details

Quality Control

Our Nilutamide-D6 is manufactured under strict quality systems to ensure exceptional isotopic purity and chemical integrity, meeting the stringent requirements of analytical research. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for isotopic enrichment (typically ≥98% D), chemical purity (by HPLC), and identity confirmation (by NMR and MS). We support compliance with cGMP, GLP, and ICH Q2(R1) guidelines for analytical procedure validation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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 (D)	≥98 atom % D
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.