Description

Sorafenib Tosylate is a potent small-molecule kinase inhibitor used in targeted cancer therapy. This active pharmaceutical ingredient (API) is critical for the formulation of medications designed to treat advanced renal cell carcinoma and hepatocellular carcinoma. It is primarily required by pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in oncology drug development and production.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of anti-cancer drugs, specifically kinase inhibitor therapies.
• Oncology Research: A key reference standard and biochemical tool for studying kinase signaling pathways, tumor angiogenesis, and cell proliferation in preclinical cancer research.
• Formulation Development: Used in the development of various dosage forms, including tablets and capsules, requiring high-purity active ingredients.
• Contract Manufacturing: Supplied to CDMOs for the commercial-scale production of finished dosage forms under cGMP conditions.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in pharmaceutical laboratories.

Basic Information

Product Name	Sorafenib Tosylate
CAS No.	475207-59-1
Molecular Formula	C₂₁H₁₆ClF₃N₄O₃ • C₇H₈O₃S
Molecular Weight	637.0 g/mol
Synonyms	Sorafenib tosylate salt; BAY 43-9006 tosylate; Nexavar (brand name API); 4-[4-[[4-Chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide; p-toluenesulfonate; Sorafenib p-toluenesulfonate; Sorafenib 4-methylbenzenesulfonate
EINECS	Contact for details

Quality Control

Our Sorafenib Tosylate is manufactured and tested under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification, purity assay, and impurity profiling via HPLC, to ensure it meets stringent pharmaceutical-grade specifications. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance with relevant 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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment 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)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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