Description

Filgotinib Maleate is a high-purity, small molecule active pharmaceutical ingredient (API) with the CAS registry number 1802998-75-9. It serves as a potent and selective Janus kinase 1 (JAK1) inhibitor, offering significant value in the development of targeted immunomodulatory therapies. This compound is essential for pharmaceutical R&D, process development, and analytical reference standards. It is primarily targeted at pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions focused on autoimmune and inflammatory diseases.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in finished dosage forms for the treatment of rheumatoid arthritis, ulcerative colitis, and other autoimmune conditions.
• Research and Development: Critical for preclinical and clinical studies investigating JAK1 inhibition pathways and therapeutic efficacy.
• Process Development & Scale-up: Used in optimizing synthetic routes, purification processes, and formulation studies for commercial manufacturing.
• Analytical Reference Standard: Serves as a high-purity benchmark for quality control testing, method validation, and regulatory submissions.
• Drug Discovery: A key compound for structure-activity relationship (SAR) studies and the development of next-generation JAK inhibitors.

Basic Information

Product Name	Filgotinib Maleate
CAS No.	1802998-75-9
Molecular Formula	C₂₁H₂₃N₅O₃ • C₄H₄O₄
Molecular Weight	529.53 g/mol
Synonyms	Filgotinib maleate salt; GLPG0634; GS-6034; 2-[(3R,4R)-4-Methyl-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl]acetic acid (2Z)-but-2-enedioate; (R)-3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile maleate; JAK1 Inhibitor GLPG0634; GLPG-0634
EINECS	Contact for details

Quality Control

Our Filgotinib Maleate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities: ≤1.5% Any single impurity: ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.