Description

Abiraterone Impurity 19 is a specified impurity associated with the active pharmaceutical ingredient Abiraterone Acetate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the production and testing of Abiraterone Acetate drug substances and products to ensure purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Abiraterone Acetate bulk drug and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Used to track the formation and behavior of this specific impurity under various stress conditions and over shelf life.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Abiraterone to minimize the formation of this impurity.

Basic Information

Product Name	Abiraterone Impurity 19
CAS No.	2307194-37-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Abiraterone Related Compound 19; Abiraterone Acetate Impurity 19; (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 (IUPAC); 3β-Hydroxy-10,13-dimethyl-17-(3-pyridyl)-2,3,4,7,8,9,10,11,12,13,14,15-dodecahydro-1H-cyclopenta[a]phenanthrene; Zytiga Impurity 19; Abiraterone Process Impurity 19
EINECS	Contact for details

Quality Control

Our Abiraterone Impurity 19 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (NMR, MS) and purity determination by advanced chromatographic techniques (HPLC). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and relevant ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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