Description

Abiraterone Dimer Impurity is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of dimeric impurities during the manufacturing and quality assurance of Abiraterone Acetate, an important active pharmaceutical ingredient. It is primarily utilized by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and fine chemical industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments in impurity profiling.
• Method Development and Validation: Used to develop and validate precise HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Assurance: Critical for establishing specification limits and testing batches of Abiraterone Acetate API for dimer impurity levels.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to monitor the formation of degradation products in stability testing of drug substances and products.
• Process Chemistry Research: Aids in understanding and optimizing synthesis pathways to minimize the formation of this specific dimer impurity.

Basic Information

Product Name	Abiraterone Dimer Impurity
CAS No.	186826-70-0
Molecular Formula	C₄₈H₅₈N₂O₄
Molecular Weight	726.99 g/mol
Synonyms	Abiraterone Dimer; Abiraterone Impurity Dimer; (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]phenanthrene-3,17-diyl bis((2S)-2-methylbutanoate) Dimer; Zytiga Dimer Impurity; Abiraterone Acetate Dimer Impurity; 17-(3-Pyridinyl)androsta-5,16-dien-3β-ol acetate dimer
EINECS	Contact for details

Quality Control

Every batch of Abiraterone Dimer Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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