Description

Regorafenib Impurity 6 CAS NO 1187945-05-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of specific impurities in Regorafenib drug substances and products. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing, ensuring product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical method development, validation, and routine quality control testing of Regorafenib API (Active Pharmaceutical Ingredient).
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing characterized impurity data for drug approval processes.
• Stability Studies: Employed in forced degradation and long-term stability studies of Regorafenib to track impurity profiles over time and under various stress conditions.
• Process Chemistry R&D: Used in research and development to understand and optimize the synthesis pathway of Regorafenib, helping to minimize the formation of this specific impurity.
• Analytical Laboratory Calibration: Serves as a calibrant for sophisticated instruments like High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) systems.
• Pharmacopoeial Testing: Applicable for testing against monographs and specifications set by pharmacopoeias such as USP (United States Pharmacopeia) or EP (European Pharmacopoeia).

Basic Information

Product Name	Regorafenib Impurity 6
CAS No.	1187945-05-6
Molecular Formula	C21H15ClF4N4O3
Molecular Weight	482.81 g/mol
Synonyms	4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide; Regorafenib Related Compound 6; BAY 73-4506 Impurity 6; Regorafenib Specified Impurity; Stivarga Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Regorafenib Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced analytical techniques, and a detailed Certificate of Analysis (COA) providing batch-specific data for identity, purity, and impurities is available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider desiccants or inert atmosphere conditions.

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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.