Description

Enzalutamide Impurity 7 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 Enzalutamide, an antiandrogen medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance. The use of this well-defined impurity standard is essential for method validation, stability studies, and meeting stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Enzalutamide drug substance and drug products.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the level of this specific impurity during the manufacturing process of Enzalutamide.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Enzalutamide.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and justify the control strategy.
• Research and Development: Utilized in synthetic chemistry R&D to study the formation and fate of this impurity during the API synthesis.

Basic Information

Product Name	Enzalutamide Impurity 7
CAS No.	2030242-21-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Enzalutamide Related Compound 7; Enzalutamide EP Impurity G; Enzalutamide USP Impurity; MDV3100 Impurity 7; 4-[3-[4-Cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl]-2-fluoro-N-methylbenzamide (tentative); Enzalutamide Degradant; Enzalutamide Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Enzalutamide Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and impurity profile, typically assessed by chromatographic and spectroscopic methods.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment and handled under appropriate laboratory 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)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.