Description

Regorafenib (Hydrochloride) is a potent, orally active small molecule kinase inhibitor. This compound is of significant commercial and research interest for its targeted therapeutic action against multiple kinases involved in oncogenesis and angiogenesis. It is primarily utilized by the pharmaceutical industry for the development and production of advanced oncology treatments. The product is supplied as a high-purity active pharmaceutical ingredient (API) to meet the stringent demands of drug manufacturing and clinical research.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of oral anti-cancer medications.
• Reference standard for analytical method development and validation in quality control laboratories.
• Key intermediate in advanced pharmaceutical research and development of kinase-targeted therapies.
• Biochemical research tool for studying signal transduction pathways involving VEGFR, TIE-2, and other oncogenic kinases.
• Pre-clinical and clinical trial material for investigational new drug (IND) applications.
• Manufacturing of finished dosage forms under current Good Manufacturing Practice (cGMP) conditions.

Basic Information

Product Name	Regorafenib (Hydrochloride)
CAS No.	835621-07-3
Molecular Formula	C21H15ClF4N4O3 • HCl
Molecular Weight	500.73 g/mol (as hydrochloride salt)
Synonyms	Regorafenib HCl; Regorafenib Hydrochloride; BAY 73-4506; BAY 73-4506 Hydrochloride; 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide hydrochloride; Stivarga (brand name API); Fluoro-Sorafenib
EINECS	Contact for details

Quality Control

Our Regorafenib (Hydrochloride) is manufactured and tested to meet the highest standards of purity and consistency required for pharmaceutical applications. Each batch undergoes rigorous analytical testing, including HPLC for assay and impurity profiling, residual solvent analysis, and comprehensive identification tests. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with agreed specifications. We support development and commercial projects with material suitable for use under cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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.

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 ≤1.5% Any single unknown impurity ≤0.5%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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