Description

Abiraterone Impurity 18 is a designated impurity of the active pharmaceutical ingredient Abiraterone Acetate, a critical drug used in the treatment of metastatic castration-resistant prostate cancer. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control to ensure drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and testing of Abiraterone Acetate.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Abiraterone Acetate drug substance and finished products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine quality control testing to establish specification limits and ensure batch-to-batch consistency of the active pharmaceutical ingredient (API).
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Abiraterone formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding the synthesis pathway of Abiraterone, helping to optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Abiraterone Impurity 18
CAS No.	2307194-36-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Abiraterone Related Compound 18; Abiraterone EP Impurity I; Abiraterone Acetate Impurity 18; (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-3,6,16-trione; 6-Oxo-abiraterone; 6-Keto-abiraterone; Abiraterone Impurity I (EP); Abiraterone Process Impurity
EINECS	Contact for details

Quality Control

Our Abiraterone Impurity 18 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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