Description

n-Desmethyl Enzalutamide CAS NO 1242137-16-1 is a key pharmaceutical intermediate and metabolite of the active pharmaceutical ingredient Enzalutamide. This compound is of critical importance in the development, validation, and quality control of anti-androgen cancer therapies. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in oncology drug development and bioanalytical studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification of Enzalutamide and its metabolites in biological matrices during pharmacokinetic (PK) and bioequivalence studies.
• Metabolite Identification & Profiling: Essential for in vitro and in vivo metabolite profiling to understand the drug's metabolic pathway and safety profile.
• Analytical Method Development: Used as a critical standard in developing and validating high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS/MS) methods.
• Impurity Standard: Acts as a specified impurity standard for quality control testing of Enzalutamide active pharmaceutical ingredient (API) and finished dosage forms, ensuring compliance with ICH guidelines.
• Preclinical & Clinical Research: Supports ongoing research into prostate cancer mechanisms and the development of next-generation androgen receptor inhibitors.

Basic Information

Product Name	n-Desmethyl Enzalutamide
CAS No.	1242137-16-1
Molecular Formula	C₂₄H₂₁F₄N₄O₂
Molecular Weight	473.44 g/mol
Synonyms	N-Desmethyl Enzalutamide; MDV3100 Metabolite; 4-[3-[4-Cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl]-2-fluoro-N-methylbenzamide; Enzalutamide Impurity; Enzalutamide Metabolite; Enzalutamide Related Compound; Bicalutamide Derivative (structural class)
EINECS	Contact for details

Quality Control

Our n-Desmethyl Enzalutamide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis. We provide Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.