Description

Abiraterone-β-D-Glucuronide is a major, inactive metabolite of the anti-cancer drug abiraterone acetate, formed via glucuronidation. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (PK), and bioanalytical method validation. It is primarily needed by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in oncology drug development, clinical trial support, and regulatory submission processes for prostate cancer therapies.

Application

• Reference Standard for Bioanalysis: Serves as a certified reference material (CRM) for the quantitative analysis of abiraterone and its metabolites in biological matrices (plasma, serum) using LC-MS/MS.
• Pharmacokinetic (PK) and Metabolism Studies: Essential for investigating the metabolic pathways, clearance mechanisms, and exposure levels of abiraterone in preclinical and clinical studies.
• Drug-Drug Interaction (DDI) Research: Used to study the potential impact of other drugs on the glucuronidation pathway of abiraterone, a key factor in its efficacy and safety profile.
• Impurity Profiling and Method Development: Acts as a critical impurity or marker during the development and validation of analytical methods for abiraterone acetate drug substance and product.
• Regulatory Compliance and Submission: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive data on metabolite identification and quantification.

Basic Information

Product Name	Abiraterone-β-D-Glucuronide
CAS No.	2307194-33-6
Molecular Formula	C32H43NO8
Molecular Weight	569.69 g/mol
Synonyms	(3β)-17-(3-Pyridinyl)androsta-5,16-dien-3-yl β-D-Glucopyranosiduronic Acid; Abiraterone Glucuronide; Abiraterone D-Glucuronide; Abiraterone 3-O-β-D-Glucuronide; N-(Dehydroepiandrosterone-3-yl)-β-D-glucopyranosiduronic acid abiraterone ester; ZYTIGA Metabolite
EINECS	Contact for details

Quality Control

Our Abiraterone-β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every batch to support your research and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This product is hygroscopic (moisture-sensitive) and should be allowed to equilibrate to room temperature in a desiccator before opening to prevent condensation and degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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