Description

Abiraterone Impurity 10 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Abiraterone Acetate. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of Abiraterone-based therapies.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Abiraterone Acetate API.
• Essential for method development and validation in HPLC and UPLC analytical procedures.
• Critical component in stability studies to monitor impurity profiles over the shelf life of the drug product.
• Used in regulatory compliance and submission to agencies like the FDA and EMA, providing necessary impurity data.
• Supports quality control (QC) and quality assurance (QA) processes in GMP manufacturing environments.
• Valuable for research and development of generic versions of Abiraterone Acetate.

Basic Information

Product Name	Abiraterone Impurity 10
CAS No.	165334-69-0
Molecular Formula	C24H31NO2
Molecular Weight	365.51 g/mol
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; 3β-Hydroxy-17-(3-pyridyl)-5α-androst-16-ene; Abiraterone Related Compound; Abiraterone Process Impurity; Abiraterone Degradant
EINECS	Contact for details

Quality Control

Every batch of Abiraterone Impurity 10 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC purity determination and structural confirmation (NMR, MS), to ensure it meets 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 specified criteria.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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