Description

Regorafenib Monohydrate is a potent, small-molecule multi-kinase inhibitor used in advanced pharmaceutical research and development. This compound matters for its targeted action against a range of kinase proteins involved in oncogenesis, angiogenesis, and tumor microenvironment signaling. It is primarily needed by pharmaceutical companies, biotechnology research firms, and academic institutions engaged in the development of novel cancer therapeutics, particularly for colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma.

Application

• Pharmaceutical Active Ingredient (API): Serves as the core active pharmaceutical ingredient in the formulation of finished anti-cancer drugs.
• Oncology Research: Used as a critical reference standard and biochemical tool in preclinical studies to investigate kinase inhibition pathways.
• Drug Development: Employed in the synthesis and process development of targeted cancer therapies, including combination treatments.
• Analytical Testing: Functions as a high-purity certified reference material (CRM) for quality control and method validation in analytical laboratories (HPLC, LC-MS).
• Clinical Trial Material: Supplied as a key intermediate or finished API for use in regulated clinical trials under GMP conditions.

Basic Information

Product Name	Regorafenib Monohydrate
CAS No.	1019206-88-2
Molecular Formula	C₂₁H₁₅ClF₄N₄O₃ • H₂O
Molecular Weight	500.82 g/mol (Monohydrate)
Synonyms	Regorafenib Hydrate; BAY 73-4506 Monohydrate; 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide Monohydrate; Stivarga (Trade Name, refers to the drug product); Fluoro-sorafenib; Multikinase inhibitor BAY 73-4506; RESIHANCE (Code Name)
EINECS	Contact for details

Quality Control

Our Regorafenib Monohydrate is manufactured and tested under a strict quality management system. We provide material that meets high-purity standards suitable for pharmaceutical research and development. Comprehensive testing includes identity, assay, impurity profile, and residual solvent analysis. A detailed Certificate of Analysis (COA) is supplied with each batch, confirming compliance with agreed specifications. Custom synthesis and purification to meet specific pharmacopeial (e.g., USP) or client requirements are available.

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 dry, inert conditions to maintain stability and potency. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0% (on anhydrous basis)
Water Content (KF)	3.0% - 4.5%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm

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