Description

Fedratinib is a potent and selective small-molecule inhibitor of Janus-associated kinase 2 (JAK2) with significant therapeutic potential. This high-purity active pharmaceutical ingredient (API) is critical for pharmaceutical research and development targeting myeloproliferative neoplasms. It is essential for researchers and manufacturers in the global pharmaceutical and biotechnology sectors developing novel treatments for hematologic malignancies.

Application

• Pharmaceutical API Synthesis: Primary use as the active ingredient in the formulation of finished drug products for clinical and commercial use.
• Oncology Research: A key reference standard and tool compound for studying JAK-STAT signaling pathways and their role in diseases like myelofibrosis and polycythemia vera.
• Preclinical & Clinical Development: Serves as the critical material for conducting pharmacokinetic, pharmacodynamic, and toxicology studies required for regulatory submissions.
• Process Chemistry & Scale-Up: Used in the development and optimization of robust, cost-effective synthetic routes for commercial manufacturing.
• Analytical Method Development: Acts as a primary standard for establishing and validating HPLC, LC-MS, and other analytical methods for quality control.
• Combinatorial Chemistry & Medicinal Chemistry: Provides a core scaffold for the design and synthesis of novel JAK2 inhibitor analogs.

Basic Information

Product Name	Fedratinib
CAS No.	936091-26-8
Molecular Formula	C₂₇H₃₆F₃N₅O₃
Molecular Weight	535.60 g/mol
Synonyms	TG101348; SAR302503; N-tert-Butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide; (N-tert-Butyl-3-((5-methyl-2-((4-(2-(pyrrolidin-1-yl)ethoxy)phenyl)amino)pyrimidin-4-yl)amino)benzenesulfonamide); TG 101348; SAR 302503; Fedratinib Hydrochloride (salt form)
EINECS	Contact for details

Quality Control

Our Fedratinib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and assay, identification by spectroscopic methods (IR, NMR, MS), and stringent control of related substances and residual solvents. We provide full traceability and Certificates of Analysis (COA) compliant with cGMP guidelines for pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5%; Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤0.5%
Heavy Metals	≤20 ppm

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