Description

Apalutamide Acid Impurity is a high-purity reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Apalutamide, an active pharmaceutical ingredient used in oncology treatments. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for method development, validation, and regulatory compliance. Ensuring the integrity of this impurity standard is fundamental to maintaining drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control of Apalutamide API and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish impurity profiles and retention times.
• Regulatory Compliance & Filings: Essential for preparing impurity identification and qualification reports for regulatory submissions (e.g., FDA, EMA).
• Stability Studies: Employed to monitor the formation and levels of this specific degradation product under various stress conditions.
• Process Chemistry Research: Used by R&D scientists to understand and optimize synthesis pathways to minimize this impurity.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (USP, EP, etc.) for related substances.

Basic Information

Product Name	Apalutamide Acid Impurity
CAS No.	1332391-04-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apalutamide Related Compound; Apalutamide Degradant; Apalutamide Acidic Impurity; ARN-509 Acid Impurity; 4-[7-[6-Cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide Impurity; Apalutamide Process Impurity; Apalutamide Impurity A (Acid Form)
EINECS	Contact for details

Quality Control

Our Apalutamide Acid Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with batch-specific data to support your regulatory and research needs. Our quality commitment ensures material traceability and consistency, aligning with cGMP principles for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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