Description

Filgotinib-D4 is a deuterated isotopologue of the Janus kinase (JAK) inhibitor Filgotinib, specifically labeled with four deuterium atoms. This stable isotope-labeled compound is an essential reference standard and internal standard for the precise quantification and pharmacokinetic studies of Filgotinib in complex biological matrices. It is primarily required by pharmaceutical research and development laboratories, contract research organizations (CROs), and analytical testing facilities engaged in bioanalytical method development, drug metabolism and pharmacokinetics (DMPK) research, and clinical trial support.

Application

• Bioanalytical Reference Standard: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) and High-Performance Liquid Chromatography (HPLC) methods for the accurate quantification of Filgotinib in plasma, serum, and other biological samples.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in mass spectrometry-based studies to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of Filgotinib, enabling precise tracking of the parent drug.
• Clinical Trial Support: Essential for ensuring data accuracy and regulatory compliance in bioanalysis during Phase I-IV clinical trials for Filgotinib and related therapeutic agents.
• Pharmacological Research: Supports preclinical and clinical research into JAK inhibition for autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis.
• Quality Control and Method Validation: Employed in pharmaceutical quality control laboratories to validate analytical procedures and ensure the specificity and accuracy of assay methods for Filgotinib API and formulations.

Basic Information

Product Name	Filgotinib-D4
CAS No.	2041095-50-3
Molecular Formula	C₂₁H₁₉D₄N₅O₃
Molecular Weight	393.47 g/mol
Synonyms	GS-6034-D4; GLPG0634-D4; Deuterated Filgotinib; [D4]-Filgotinib; 2-[(3R,4S)-3-([1,1'-Biphenyl]-4-ylmethyl)-4-methyl-2,5-dioxo-1-(2,2,2-trifluoroethyl)-4-imidazolidinyl]-N-(2,2,2-trifluoroethyl)acetamide-D4; (3R,4S)-3-([1,1'-Biphenyl]-4-ylmethyl)-1-(2,2,2-trifluoroethyl)-4-methyl-4-[[2-[(2,2,2-trifluoroethyl)amino]-2-oxoethyl]amino]-2,5-imidazolidinedione-D4
EINECS	Contact for details

Quality Control

Our Filgotinib-D4 is manufactured under strict quality systems to ensure the high chemical purity and isotopic enrichment required for sensitive analytical applications. Each batch undergoes comprehensive testing, including HPLC for chemical purity, NMR and Mass Spectrometry for structural confirmation and isotopic enrichment assessment. A detailed Certificate of Analysis (COA) is provided, documenting the analytical results and confirming compliance with specifications. We support research under GMP/GLP guidelines where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccated environment upon opening to maintain stability and purity. Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH limits

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