Description

Abiraterone n-Oxide Sulfate Salt is a high-purity pharmaceutical intermediate and reference standard. This compound is critical for research and development in advanced oncology therapeutics, particularly in the synthesis and quality control of active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the development of hormone-based cancer treatments.

Application

• Pharmaceutical Intermediate: A key building block in the synthesis of Abiraterone Acetate and related steroid-based APIs.
• Reference Standard: Used for analytical method development, validation, and quality control (QC) testing in pharmaceutical manufacturing.
• Metabolite Studies: Employed in pharmacokinetic and drug metabolism research to study the metabolic pathways of Abiraterone.
• Impurity Profiling: Serves as a certified impurity standard to monitor and control related substances in final drug products.
• Preclinical Research: Utilized in laboratory studies to investigate the efficacy and mechanisms of novel therapeutic agents for prostate cancer.
• Regulatory Submissions: Provides essential data and characterization for drug master files (DMFs) and regulatory compliance dossiers (e.g., for FDA, EMA).

Basic Information

Product Name	Abiraterone n-Oxide Sulfate Salt
CAS No.	1993430-24-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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 N-Oxide Sulfate Salt; Abiraterone N-Oxide Sulfate; Abiraterone Impurity Sulfate Salt; Abiraterone Related Compound Sulfate Salt
EINECS	Contact for details

Quality Control

Our Abiraterone n-Oxide Sulfate Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and structural confirmation via spectroscopic methods (NMR, MS). We provide full traceability and Certificates of Analysis (COA) are available for every shipment, ensuring compliance with cGMP guidelines and customer-specific requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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