Description

Apalutamide-D3 CAS NO 1638885-61-6 is a deuterium-labeled analog of the nonsteroidal antiandrogen drug Apalutamide. This stable isotope-labeled compound is a critical tool in modern pharmaceutical research and development, enabling precise and reliable pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in advanced drug discovery and bioanalytical method development.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a high-purity, isotopically labeled internal standard for the accurate quantification of Apalutamide in complex biological matrices like plasma, serum, and tissue homogenates.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for conducting mass spectrometry-based studies to understand the absorption, distribution, metabolism, and excretion (ADME) profile of Apalutamide.
• Bioanalytical Method Development and Validation: Used to develop, optimize, and validate robust, sensitive, and specific analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Clinical Research Support: Facilitates therapeutic drug monitoring and precise pharmacokinetic profiling during clinical trials for prostate cancer treatments.
• Metabolite Identification and Profiling: Aids in the identification and structural elucidation of metabolites generated from Apalutamide in in vitro and in vivo studies.
• Quality Control and Reference Standard: Can be employed as a certified reference material (CRM) to ensure the accuracy and consistency of analytical results in quality control laboratories.

Basic Information

Product Name	Apalutamide-D3
CAS No.	1638885-61-6
Molecular Formula	C₂₁H₁₂D₃F₄N₄O₂S
Molecular Weight	464.45 g/mol
Synonyms	ARN-509 D3; Apalutamide (phenyl-d3); 4-[7-[6-Cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide (phenyl-d3); JNJ-56021927 D3; Erleada-d3; Deuterated Apalutamide; (4-[7-[6-Cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide-d3)
EINECS	Contact for details

Quality Control

Our Apalutamide-D3 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity, essential for sensitive analytical applications. Each batch is characterized using advanced techniques including NMR, HPLC, and high-resolution mass spectrometry. A comprehensive Certificate of Analysis (COA) detailing isotopic enrichment, chemical purity, and analytical results is provided with every shipment to support your regulatory and research documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). For long-term storage, consider storage under an inert atmosphere. 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 (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (deuterium, D)	≥98 atom % D
Chemical Purity	≥95%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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