Description

Abiraterone Impurity 15 is a designated impurity reference standard used in the analytical profiling of the active pharmaceutical ingredient, Abiraterone Acetate. This compound is critical for pharmaceutical research and development, specifically for method validation, stability studies, and ensuring the purity and safety of the final drug product. It is an essential material for quality control laboratories in the pharmaceutical industry, regulatory bodies, and contract research organizations (CROs) focused on oncology therapeutics.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Abiraterone Acetate API.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control.
• Essential for conducting stability-indicating studies and forced degradation studies to assess drug shelf-life.
• Used in regulatory compliance and submission packages to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Supports pharmaceutical research into the metabolism and degradation pathways of Abiraterone.
• Serves as a high-purity benchmark in contract manufacturing and testing facilities.

Basic Information

Product Name	Abiraterone Impurity 15
CAS No.	2141996-19-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Abiraterone Related Compound 15; Abiraterone Acetate Impurity 15; (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-based); ZYTIGA Impurity 15; 3β-Hydroxy-17-(3-pyridyl)-5α-androst-16-ene (structural descriptor); Abiraterone Process Impurity; Abiraterone Degradant
EINECS	Contact for details

Quality Control

Every batch of Abiraterone Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. Production is aligned with cGMP principles to ensure consistency and reliability for pharmaceutical applications.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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