Description

Abiraterone 5,6-Dihydro Impurity/17-(3-Pyridinyl)-(3β,5α)-Androst-16-En-3-Ol is a critical pharmaceutical reference standard and impurity used in the development and quality control of Abiraterone Acetate, a key active pharmaceutical ingredient (API) for treating metastatic castration-resistant prostate cancer. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances during manufacturing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of the 5,6-dihydro impurity in Abiraterone Acetate API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to ensure API and drug product batches meet specified impurity limits and regulatory requirements.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity) over the drug's shelf life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate comprehensive impurity profiling.
• Research & Development: Utilized in synthetic chemistry R&D to understand the impurity formation pathway and optimize the manufacturing process to minimize its presence.

Basic Information

Product Name	Abiraterone 5,6-Dihydro Impurity/17-(3-Pyridinyl)-(3β,5α)-Androst-16-En-3-Ol
CAS No.	219843-75-1
Molecular Formula	C26H35NO
Molecular Weight	377.57 g/mol
Synonyms	17-(3-Pyridinyl)androsta-5,16-dien-3β-ol (5,6-dihydro derivative); Abiraterone Dihydro Impurity; Abiraterone Related Compound C; (3β)-17-(3-Pyridinyl)androsta-5,16-dien-3-ol; 17-(Pyridin-3-yl)androsta-5,16-dien-3β-ol; ZYTIGA Impurity C; Abiraterone Process Impurity; 5,6-Dihydroabiraterone
EINECS	Contact for details

Quality Control

Our Abiraterone 5,6-Dihydro Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR, MS), and control of residual solvents and other specified impurities to ensure compliance with ICH guidelines and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated 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)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0%
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.