Description

Abiraterone Impurity 4 is a specified impurity of the active pharmaceutical ingredient Abiraterone Acetate, a critical drug used in the treatment of prostate cancer. This impurity is essential for pharmaceutical manufacturers to monitor and control to ensure the safety, efficacy, and regulatory compliance of the final drug product. It serves as a vital reference standard in analytical method development, validation, and quality control processes within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use 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 sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing of active pharmaceutical ingredients (APIs) to ensure compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and chemistry of Abiraterone.

Basic Information

Product Name	Abiraterone Impurity 4
CAS No.	2118-32-3
Molecular Formula	C24H31NO
Molecular Weight	349.51 g/mol
Synonyms	(3S,8R,9S,10R,13S,14S)-3-Hydroxy-10,13-dimethyl-17-(pyridin-3-yl)-2,3,4,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-6-one; 3β-Hydroxy-17-(3-pyridyl)androsta-5,16-dien-6-one; Abiraterone Related Compound 4; Abiraterone EP Impurity D; Abiraterone USP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Abiraterone Impurity 4 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. Our products are supplied with a detailed Certificate of Analysis (COA) that includes data from HPLC purity, related substance analysis, and structural confirmation (NMR, MS). We ensure compliance with relevant pharmacopeial standards and ICH guidelines for impurities. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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