Description

[2H4]-Imatinib is a deuterated analog of the well-known tyrosine kinase inhibitor, Imatinib, specifically labeled with four deuterium atoms. This stable isotope-labeled compound is an essential internal standard for the precise quantification of Imatinib in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in pharmacokinetic studies, drug metabolism research, and bioanalytical method development. The use of this labeled standard ensures superior accuracy and reliability in data, addressing critical needs for quality assurance in drug development and regulatory compliance.

Application

• Bioanalytical Method Development and Validation: Serves as a critical internal standard for developing and validating sensitive and specific LC-MS/MS methods for Imatinib quantification.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables accurate measurement of Imatinib concentration in plasma, serum, and tissue samples to study absorption, distribution, metabolism, and excretion (ADME).
• Drug Metabolism Research: Used in metabolite profiling and identification studies to understand the biotransformation pathways of Imatinib.
• Clinical Trial Support: Provides reliable data for therapeutic drug monitoring (TDM) and dose optimization studies in clinical research settings.
• Forensic and Anti-Doping Analysis: Acts as a reference standard in confirmatory testing where precise measurement of drug levels is legally or ethically mandated.
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and assay validation for Imatinib active pharmaceutical ingredient (API) and finished drug products.

Basic Information

Product Name	[2H4]-Imatinib
CAS No.	1134803-16-9
Molecular Formula	C29H27D4N7O
Molecular Weight	494.62 g/mol
Synonyms	Deuterated Imatinib (d4); Imatinib-d4; STI571-d4; Gleevec-d4; Glivec-d4; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide-d4; CGP 57148B-d4
EINECS	Contact for details

Quality Control

Every batch of [2H4]-Imatinib is manufactured under strict quality management systems and undergoes comprehensive analytical testing to ensure identity, purity, and isotopic enrichment. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes data for critical parameters such as assay (HPLC), isotopic purity (NMR/MS), chemical purity, and residual solvent content. Our quality commitment aligns with the standards expected for high-purity reference materials used in 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 product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
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.