Description

Enzalutamide Impurity CAS NO 1839619-50-9 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Enzalutamide. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Enzalutamide drug substance and finished products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical QC laboratories to ensure adherence to ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the active pharmaceutical ingredient.

Basic Information

Product Name	Enzalutamide Impurity
CAS No.	1839619-50-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Enzalutamide Related Compound; Enzalutamide Degradant; Enzalutamide Process Impurity; MDV3100 Impurity; 4-[3-[4-Cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl]-2-fluoro-N-methylbenzamide (IUPAC); Xtandi Impurity; Androgen Receptor Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Enzalutamide Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

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 in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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.