Description

Enzalutamide Impurity 20 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Enzalutamide. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for analytical chemists, quality assurance professionals, and researchers in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Enzalutamide Impurity 20 in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Enzalutamide to minimize the formation of this impurity.

Basic Information

Product Name	Enzalutamide Impurity 20
CAS No.	1242137-19-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Enzalutamide Related Compound 20; MDV3100 Impurity 20; Xtandi Impurity 20; 4-[3-[4-Cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl]-2-fluoro-N-methylbenzamide (IUPAC); Enzalutamide Process Impurity; Enzalutamide Degradant; Enzalutamide Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Enzalutamide Impurity 20 CAS NO 1242137-19-4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

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 to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

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

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