Description

Regorafenib Impurity 9 is a specified impurity of the anticancer pharmaceutical agent Regorafenib, identified by CAS No. 2188236-16-8. This compound is critical for pharmaceutical research and development, serving as a key reference standard for method development, validation, and quality control testing of the active pharmaceutical ingredient (API). It is primarily needed by analytical laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Regorafenib API and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) to separate and analyze process-related impurities.
• Quality Control & Assurance: Employed in routine batch release testing to monitor impurity profiles and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of degradation products in Regorafenib formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Regorafenib.

Basic Information

Product Name	Regorafenib Impurity 9
CAS No.	2188236-16-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Regorafenib Related Compound 9; Regorafenib Specified Impurity 9; BAY 73-4506 Impurity 9; 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide Impurity; Stivarga Impurity 9
EINECS	Contact for details

Quality Control

Our Regorafenib Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity (HPLC), 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 relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.