Description

n-Desmethyl Imatinib-D8 is a high-purity, deuterium-labeled internal standard critical for accurate quantitative bioanalysis in pharmaceutical research and development. This stable isotope-labeled analog of the active metabolite of Imatinib is essential for ensuring precision and reliability in mass spectrometry-based assays. It is primarily utilized by analytical chemists, pharmacokinetic researchers, and quality control laboratories within the pharmaceutical and biotechnology sectors for method development, validation, and routine drug monitoring.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the precise LC-MS/MS quantification of Imatinib and its metabolites in biological matrices (plasma, serum, tissue).
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Method Development and Validation: Used as a reference standard to develop, optimize, and validate robust analytical methods compliant with GLP and GMP guidelines.
• Drug Metabolism Studies: Facilitates the identification and quantification of specific metabolic pathways of Imatinib, aiding in metabolite profiling.
• Therapeutic Drug Monitoring (TDM): Supports accurate assay calibration for monitoring Imatinib plasma concentrations in patients to optimize dosing regimens and efficacy.
• Impurity Profiling and Characterization: Acts as a reference marker in the analysis of drug substance and product for related substance testing.

Basic Information

Product Name	n-Desmethyl Imatinib-D8
CAS No.	1185103-28-9
Molecular Formula	C28H23D8N7O
Molecular Weight	~ 481.62 g/mol
Synonyms	N-Desmethyl Imatinib-d8; Imatinib N-Desmethyl Metabolite-d8; STI571 N-Desmethyl-d8; CGP 74588-d8; 4-[(4-Methyl-1-piperazinyl-d8)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide; Dextromethorphan Impurity D8; Gleevec Metabolite-d8
EINECS	Contact for details

Quality Control

Every batch of n-Desmethyl Imatinib-D8 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with research and analytical standards. A comprehensive Certificate of Analysis (COA), detailing purity, isotopic enrichment, and impurity profiles, is provided with each shipment to guarantee traceability and reliability for your critical applications.

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 must be kept in a dry environment. For long-term storage, consider desiccation and under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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