Description

Enzalutamide Impurity 7 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Enzalutamide. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a key reference material for method development, validation, and routine batch testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Enzalutamide API.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of degradation products in Enzalutamide formulations under various storage conditions.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the manufacturing process to minimize this impurity.

Basic Information

Item	Details
Product Name	Enzalutamide Impurity 7
CAS No.	1802242-46-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Enzalutamide Related Compound 7; MDV 3100 Impurity 7; Xtandi Impurity 7; 4-[3-[4-Cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl]-2-fluoro-N-methylbenzamide; Enzalutamide EP Impurity G; Enzalutamide USP Impurity 7
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 identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic techniques to ensure compliance with ICH guidelines and customer-specific requirements. Comprehensive Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

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%
Water Content (KF)	≤ 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.