Description

Abiraterone Metabolite 1 is a key intermediate and reference standard in the synthesis and analytical profiling of abiraterone acetate, a critical active pharmaceutical ingredient. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the production of high-purity active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories focused on oncology therapeutics and steroid synthesis.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and qualification of abiraterone and its related substances in drug substances and products via HPLC, LC-MS, and other analytical methods.
• Active Pharmaceutical Ingredient (API) Intermediate: Serves as a critical building block in the multi-step synthetic pathway for the production of abiraterone acetate and other related steroid-based therapeutics.
• Metabolite Studies: Employed in preclinical and clinical research to investigate the metabolic pathways, pharmacokinetics, and pharmacodynamics of abiraterone therapy.
• Impurity Profiling: Essential for identifying, characterizing, and controlling process-related impurities and degradation products in abiraterone acetate batches to ensure compliance with ICH Q3A/B guidelines.
• Method Development and Validation: A crucial component for developing and validating robust analytical methods for quality control (QC) laboratories in the pharmaceutical industry.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., with the FDA, EMA) to demonstrate thorough understanding and control of the drug substance.

Basic Information

Product Name	Abiraterone Metabolite 1
CAS No.	1940176-03-3
Molecular Formula	C24H31NO2
Molecular Weight	365.51 g/mol
Synonyms	3β-Hydroxy-17-(3-pyridyl)androsta-5,16-dien-16-carboxylic acid; 17-(3-Pyridyl)androsta-5,16-dien-3β-ol-16-carboxylic acid; Abiraterone Acid; Abiraterone Carboxylic Acid Metabolite; Abiraterone M1; Abiraterone Metabolite M1; 16-Carboxyabiraterone
EINECS	Contact for details

Quality Control

Our Abiraterone Metabolite 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, chiral purity determination, and identification by spectroscopic methods (IR, NMR, MS) to ensure identity and consistency. We provide detailed Certificates of Analysis (COA) with each shipment, containing batch-specific results. Our quality standards are designed to meet the rigorous requirements for pharmaceutical reference standards and advanced intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time conforms to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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