Description

Apalutamide D4 CAS NO 1638885-65-0 is a deuterated isotopologue of the non-steroidal antiandrogen drug Apalutamide, where four hydrogen atoms are replaced with deuterium. This stable isotope-labeled compound is essential for conducting high-quality pharmacokinetic and metabolic studies, providing critical internal standards for mass spectrometry. It is primarily needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical chemists working on drug development and bioanalytical method validation.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference standard in quantitative bioanalysis for accurate measurement of Apalutamide in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in absorption, distribution, metabolism, and excretion (ADME) research to track the parent drug's fate.
• Metabolite Identification: Aids in the structural elucidation of drug metabolites using mass spectrometry.
• Clinical Research Support: Enables precise and reliable drug concentration monitoring in patient plasma samples during clinical trials.
• Method Development and Validation: Essential for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Quality Control in Reference Material Production: Used to certify and calibrate unlabeled Apalutamide reference standards.

Basic Information

Product Name	Apalutamide D4
CAS No.	1638885-65-0
Molecular Formula	C₂₁H₁₁D₄F₄N₄O₂S
Molecular Weight	477.46 g/mol
Synonyms	ARN-509 D4; JNJ-56021927 D4; 4-[7-[4-Cyano-3-(trifluoromethyl)phenyl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl]-2-fluoro-N-methylbenzamide D4; Deuterated Apalutamide; Apalutamide-d4; [²H₄]-Apalutamide
EINECS	Contact for details

Quality Control

Our Apalutamide D4 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and LC-MS, to confirm identity, purity, and isotopic enrichment. A comprehensive Certificate of Analysis (COA) detailing all specifications is provided with every shipment, supporting compliance with GLP and ISO standards.

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 should be kept in a dry environment. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity	≥98.0 atom % D
Chemical Purity	≥95.0%
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.