Description

n-Desmethyl Imatinib Mesylate is a key pharmaceutical intermediate and metabolite of the tyrosine kinase inhibitor Imatinib. This compound is of significant importance for research and development in the fields of oncology and pharmacokinetics, serving as a critical reference standard and a building block for novel therapeutic agents. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug metabolism studies, bioanalytical method development, and impurity profiling.

Application

• Primary reference standard for the quantification of Imatinib and its metabolites in bioanalytical studies (e.g., LC-MS/MS).
• Critical impurity standard for quality control and regulatory filing of Imatinib Mesylate active pharmaceutical ingredient (API).
• Key intermediate in the research-scale synthesis of novel kinase inhibitor derivatives and prodrugs.
• Essential reagent for in-vitro and in-vivo drug metabolism and pharmacokinetic (DMPK) studies.
• Used in the development and validation of analytical methods for compliance with ICH guidelines.
• Important material for stability studies and forced degradation studies of Imatinib-based drug products.

Basic Information

Item	Detail
Product Name	n-Desmethyl Imatinib Mesylate
CAS No.	404844-03-7
Molecular Formula	C28H31N7O · CH4O3S
Molecular Weight	589.68 g/mol
Synonyms	N-Desmethyl Imatinib Mesylate; Imatinib N-Desmethyl Metabolite Mesylate; STI571 N-Desmethyl Mesylate; CGP 74588 Mesylate; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide Methanesulfonate; N-Desmethyl Gleevec Mesylate; Imatinib Metabolite Mesylate
EINECS	Contact for details

Quality Control

Our n-Desmethyl Imatinib Mesylate is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of specified impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with relevant standards for pharmaceutical reference materials.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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