Description

Apalutamide Desfluoro Impurity is a key pharmaceutical reference standard used in the development and quality control of the active pharmaceutical ingredient (API) Apalutamide. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark for analytical method validation and impurity profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and testing of oncology therapeutics.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of process-related impurities in Apalutamide API.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of Apalutamide drug substances and products.
• Research & Development: Used in synthetic chemistry R&D to study degradation pathways and optimize purification processes for Apalutamide.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing to ensure product specifications are met.

Basic Information

Product Name	Apalutamide Desfluoro Impurity
CAS No.	1332389-57-7
Molecular Formula	C21H15F4N5O2S
Molecular Weight	485.43 g/mol
Synonyms	Desfluoro Apalutamide; Apalutamide Desfluoro Analog; 4-[7-[6-Cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-thia-1,8-diazaspiro[4.5]dec-1-en-2-yl]-2-fluoro-N-methylbenzamide; ARN-509 Desfluoro Impurity; JNJ-56021927 Desfluoro Related Compound; (2S)-N-(4-Cyano-3-(trifluoromethyl)phenyl)-3-((4-fluorophenyl)sulfonyl)-2-hydroxy-2-methylpropanamide Desfluoro Derivative
EINECS	Contact for details

Quality Control

Our Apalutamide Desfluoro Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive).

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% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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