Description

Regorafenib Impurity 10 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 during the development and manufacturing of the active pharmaceutical ingredient (API) Regorafenib. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, ensuring product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Regorafenib.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Regorafenib API and drug products meet stringent purity specifications per ICH guidelines.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various storage conditions.
• Research and Development: Facilitates process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Regorafenib Impurity 10
CAS No.	2098799-12-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Regorafenib Related Compound 10; Regorafenib Impurity; 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide Impurity; BAY 73-4506 Impurity 10; Stivarga Impurity 10
EINECS	Contact for details

Quality Control

Our Regorafenib Impurity 10 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with current industry and regulatory standards for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.