Description

Abiraterone-D4 is a deuterated isotopologue of the active pharmaceutical ingredient Abiraterone, specifically labeled with four deuterium atoms. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical R&D and clinical laboratories focused on advancing prostate cancer therapies and conducting high-precision drug metabolism research.

Application

• Internal Standard for LC-MS/MS: Primary application as a high-purity, stable isotope-labeled internal standard for the precise quantification of Abiraterone and its metabolites in biological matrices via liquid chromatography-tandem mass spectrometry (LC-MS/MS).
• Pharmacokinetic (PK) Studies: Enables accurate determination of drug concentration-time profiles, bioavailability, and half-life in preclinical and clinical studies for Abiraterone acetate.
• Metabolite Identification & Profiling: Used in drug metabolism and disposition (DMPK) studies to track and quantify parent drug and metabolite formation, aiding in pathway elucidation.
• Bioanalytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating robust, GLP-compliant analytical methods for regulatory submissions.
• Clinical Trial Support: Provides essential data integrity for bioanalysis in Phase I-IV clinical trials of Abiraterone-based therapies.
• Reference Material for Quality Control: Acts as a certified reference material (CRM) for calibrating instruments and verifying assay performance in quality control laboratories.

Basic Information

Product Name	Abiraterone-D4
CAS No.	2122245-62-7
Molecular Formula	C24H27D4NO2
Molecular Weight	369.55 g/mol (approximate)
Synonyms	(3S,8R,9S,10R,13S,14S)-10,13-Dimethyl-17-(pyridin-3-yl)-2,3,4,7,8,9,10,11,12,13,14,15-dodecahydro-1H-cyclopenta[a]phenanthren-3-ol-D4; 17-(3-Pyridyl)androsta-5,16-dien-3β-ol-D4; Abiraterone (D4); Abiraterone-d4; Deuterated Abiraterone; Abiraterone Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Abiraterone-D4 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use in regulated environments. Certificates of Analysis (COA) are supplied with each shipment, detailing critical parameters such as isotopic purity, chemical purity, and absence of interfering impurities. Our quality commitment ensures the material is suitable for GLP and GMP-compliant bioanalysis.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (Deuterium Content)	≥98.0 atom % D
Chemical Purity (by HPLC)	≥95.0%
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤1.0%

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