Description

Enzalutamide Impurity 9 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Enzalutamide, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Enzalutamide API and related drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to accurately detect and quantify this specific impurity.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine batch testing to monitor impurity profiles and ensure compliance with ICH guidelines and pharmacopeial standards.
• Stability Studies: Employed to identify and track the formation of degradation products in Enzalutamide formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to support the development of robust manufacturing processes for Enzalutamide.

Basic Information

Product Name	Enzalutamide Impurity 9
CAS No.	1895865-10-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Enzalutamide Related Compound 9; Enzalutamide EP Impurity 9; Enzalutamide USP Impurity 9; MDV3100 Impurity 9; 4-[3-[4-Cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl]-2-fluoro-N-methylbenzamide (proposed); Xtandi Impurity 9
EINECS	Contact for details

Quality Control

Our Enzalutamide Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, LC-MS, and NMR, to confirm identity and ensure high purity. Certificates of Analysis (COA) are provided, detailing comprehensive test results and confirming compliance with relevant standards for pharmaceutical impurities. We support our clients' needs for regulatory filings with full traceability and documentation.

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 storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.