Description

Abiraterone Acetate Dimer Impurity is a critical pharmaceutical reference standard used to monitor and control the quality of the active pharmaceutical ingredient (API), Abiraterone Acetate. This specific impurity, identified by CAS NO 186826-68-6, is essential for ensuring the safety, efficacy, and regulatory compliance of finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Abiraterone Acetate-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of the dimer impurity in Abiraterone Acetate API and its formulations.
• Method Development and Validation: Used in analytical research to develop and validate robust HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control (QC) Testing: A critical component in the routine QC testing of Abiraterone Acetate batches to ensure they meet stringent pharmacopeial (e.g., USP, EP) and internal specification limits.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions, supporting shelf-life determination and packaging decisions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Used in process chemistry R&D to understand and minimize the formation of this dimer during the synthesis and purification of Abiraterone Acetate.

Basic Information

Product Name	Abiraterone Acetate Dimer Impurity
CAS No.	186826-68-6
Molecular Formula	C₅₀H₅₈N₂O₆
Molecular Weight	775.01 g/mol
Synonyms	Abiraterone Acetate Dimer; Abiraterone Acetate Impurity Dimer; (3β)-17-(3-Pyridinyl)androsta-5,16-dien-3-yl acetate dimer; Zytiga dimer impurity; Abiraterone dimer; Abiraterone acetate related compound Dimer; CB-7630 dimer impurity
EINECS	Contact for details

Quality Control

Every batch of Abiraterone Acetate Dimer Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with stated specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
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)	≤ 1.0%

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