Description

Regorafenib CAS NO 755037-03-7 is a small molecule kinase inhibitor belonging to the class of diphenylurea derivatives. This compound is of critical importance as a targeted therapeutic agent, primarily used in oncology to inhibit multiple cancer-promoting kinases. It is essential for pharmaceutical manufacturers and research institutions engaged in the development and production of advanced cancer treatments, particularly for colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in formulated anti-cancer medications.
• Oncology Research: A vital reference standard and tool compound for in-vitro and in-vivo studies targeting VEGFR, TIE2, and other oncogenic kinases.
• Drug Development: Used in preclinical and clinical development pipelines for novel targeted cancer therapies and combination regimens.
• Generic Drug Manufacturing: Sourcing of high-purity regorafenib for the production of generic versions following patent expiry.
• Biochemical Assays: Employed as a selective inhibitor in high-throughput screening and kinase profiling assays.
• Metabolite Synthesis: Serves as a precursor for the synthesis of key metabolites like M-2 and M-5 for pharmacokinetic studies.

Basic Information

Product Name	Regorafenib
CAS No.	755037-03-7
Molecular Formula	C₂₁H₁₅ClF₄N₄O₃
Molecular Weight	482.82 g/mol
Synonyms	BAY 73-4506; Regorafenib Monohydrate; 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide; Stivarga (Brand Name); Fluoro-Sorafenib; N-(4-Chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)urea
EINECS	Contact for details

Quality Control

Our Regorafenib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent pharmaceutical-grade specifications, including identity, purity, and impurity profile verification. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and heavy metals is provided with every shipment. Production adheres to cGMP guidelines where applicable, supporting regulatory submissions for drug master files (DMF).

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccated environment to maintain stability and potency. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single unknown impurity ≤ 0.10%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Meets ICH Q3C guidelines

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