Description

Gilteritinib is a potent and selective small-molecule inhibitor of FMS-like tyrosine kinase 3 (FLT3), designed for targeted therapeutic intervention. This compound is of critical importance in the field of precision oncology, offering a mechanism-based approach for treating specific hematologic malignancies. It is primarily required by pharmaceutical research organizations, contract development and manufacturing organizations (CDMOs), and academic institutions engaged in the development of novel anticancer agents and targeted therapies.

Application

• Active Pharmaceutical Ingredient (API): Serves as the core active component in the formulation of finished dosage forms for targeted cancer therapy.
• Oncology Research: Used as a critical reference standard and investigational tool in preclinical and clinical studies focusing on FLT3-mutated cancers, particularly acute myeloid leukemia (AML).
• Biochemical Assay Development: Employed in high-throughput screening and biochemical assays to study FLT3 kinase inhibition and signal transduction pathways.
• Drug Discovery & Development: Functions as a key intermediate or lead compound in medicinal chemistry programs aimed at developing next-generation FLT3 inhibitors.
• Pharmacology & Toxicology Studies: Utilized in ADME (Absorption, Distribution, Metabolism, and Excretion) and safety assessment studies to support regulatory filings.
• Reference Standard: Provides a high-purity benchmark for quality control, method validation, and impurity profiling in analytical laboratories.

Basic Information

Product Name	Gilteritinib
CAS No.	1254053-43-4
Molecular Formula	C29H44N8O3
Molecular Weight	552.71 g/mol
Synonyms	ASP2215; Xospata (brand name); 6-Ethyl-3-({3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}amino)-5-[(tetrahydro-2H-pyran-4-yl)amino]pyrazine-2-carboxamide; Gilteritinib Fumarate (salt form); FLT3/AXL Inhibitor; FLT3 Tyrosine Kinase Inhibitor
EINECS	Contact for details

Quality Control

Our Gilteritinib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, purity assay, and impurity profiling via advanced techniques like HPLC and LC-MS, to ensure it meets stringent specifications for pharmaceutical research. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance with your research and development requirements.

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 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%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Water Content (KF)	≤1.0%
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.