Description

Genfatinib-D3 (Imatinib-D3) is a deuterated isotopologue of the well-known tyrosine kinase inhibitor, Imatinib, specifically labeled with three deuterium atoms. This stable isotope-labeled compound is a critical internal standard for the precise and accurate quantification of Imatinib in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is an essential tool for pharmaceutical research and development laboratories, clinical research organizations, and bioanalytical service providers focused on pharmacokinetic studies, therapeutic drug monitoring, and drug metabolism research.

Application

• Primary use as an internal standard for the quantitative bioanalysis of Imatinib in plasma, serum, and tissue samples.
• Essential for pharmacokinetic (PK) and pharmacodynamic (PD) studies during drug development.
• Critical component in therapeutic drug monitoring (TDM) assays to optimize patient dosing regimens.
• Used in drug metabolism and disposition (DMPK) research to track parent drug and metabolites.
• Supports clinical research and clinical trial sample analysis for oncology treatments.
• Valuable for forensic toxicology and doping control applications requiring high specificity.
• Enables method development and validation in regulatory-compliant bioanalytical laboratories (following FDA/EMA guidelines).

Basic Information

Product Name	Genfatinib-D3 (Imatinib-D3)
CAS No.	1134803-18-1
Molecular Formula	C₂₉H₂₈D₃N₇O
Molecular Weight	494.61 g/mol
Synonyms	Imatinib-d3; STI571-d3; Gleevec-d3; Glivec-d3; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide-d3; CGP 57148B-d3; Imatinib Mesylate-d3 (salt form)
EINECS	Contact for details

Quality Control

Our Genfatinib-D3 is manufactured under strict quality systems to ensure the high purity and isotopic enrichment required for sensitive mass spectrometry applications. Each batch is characterized by advanced analytical techniques including NMR, HPLC, and MS to confirm chemical and isotopic purity. A comprehensive Certificate of Analysis (COA) is provided, detailing assay, isotopic purity (D-enrichment), and impurity profiles, supporting use in GLP and GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 99.0 atom % D
Chemical Purity (by HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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