Description

Abiraterone Impurity 9 is a designated impurity of the active pharmaceutical ingredient Abiraterone Acetate, a critical drug used in the treatment of prostate cancer. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for ensuring the purity, safety, and efficacy of Abiraterone-based drug products.

Application

• Primary use as a Pharmaceutical Reference Standard for the identification and quantification of impurities in Abiraterone Acetate API and finished dosage forms.
• Critical for Analytical Method Development and Validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Essential material for Stability Studies and forced degradation studies to understand the degradation pathways of Abiraterone.
• Used in Regulatory Submissions (e.g., for FDA, EMA) to establish impurity profiles and specifications.
• Supports Research and Development of new synthetic routes and purification processes for Abiraterone Acetate.
• Employed in Pharmacopoeial Testing to verify compliance with monographs from USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Abiraterone Impurity 9
CAS No.	165334-72-5
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)androsta-5,16-diene; Abiraterone Related Compound; Abiraterone EP Impurity; Abiraterone USP Impurity; Abiraterone Process Impurity; 17-(3-Pyridyl)androsta-5,16-dien-3β-ol
EINECS	Contact for details

Quality Control

Our Abiraterone Impurity 9 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with specified purity criteria, typically ≥95% (HPLC). The material is suitable for use as a reference standard in compliance with ICH guidelines.

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 desiccated environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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