Description

Gilteritinib Hemifumarate is a high-purity, small molecule pharmaceutical active ingredient classified as a potent and selective FLT3/AXL kinase inhibitor. This compound is of critical importance in the research and development of targeted cancer therapies, particularly for acute myeloid leukemia (AML). It is primarily required by pharmaceutical manufacturers, advanced research institutions, and contract development and manufacturing organizations (CDMOs) engaged in oncology drug development and production.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in finished dosage forms for targeted cancer therapy.
• Oncology Research: Critical reference standard and biochemical tool for in-vitro and in-vivo studies targeting FLT3-mutated cancers.
• Drug Development: Serves as a key intermediate in the formulation development and clinical trial material (CTM) manufacturing for novel AML treatments.
• Preclinical Studies: Used in pharmacokinetics (PK), pharmacodynamics (PD), and toxicology assessments during the drug discovery pipeline.
• Analytical Standard: Employed as a high-purity standard for method development and validation in quality control laboratories (e.g., HPLC, LC-MS).
• Combinatorial Therapy Research: Investigated in combination with other chemotherapeutic agents to enhance efficacy and overcome drug resistance.

Basic Information

Product Name	Gilteritinib Hemifumarate
CAS No.	1254053-84-3
Molecular Formula	C29H44N8O3 • 0.5C4H4O4
Molecular Weight	549.65 g/mol (free base: 485.62)
Synonyms	ASP2215 Hemifumarate; Gilteritinib Fumarate (1:0.5); 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 hemifumarate; Xospata (Brand Name API); FLT3 Inhibitor ASP2215; AXL Kinase Inhibitor
EINECS	Contact for details

Quality Control

Our Gilteritinib Hemifumarate is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and strength, aligning with ICH Q7 guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to support your regulatory and development needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure containers are sealed after each use to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Residue on Ignition	≤ 0.1%

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