Description

n-Desmethyl Imatinib is a key pharmaceutical intermediate and metabolite of the blockbuster oncology drug Imatinib mesylate. Its primary value lies in enabling advanced pharmaceutical research, including metabolite profiling, pharmacokinetic studies, and the development of novel therapeutic agents. This compound is essential for pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions focused on oncology drug development and bioanalytical method validation.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the quantification and identification of the active metabolite in bioanalytical studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Used in in vitro and in vivo studies to understand the metabolic pathways and clearance mechanisms of Imatinib.
• Impurity Profiling: Employed as a known impurity standard in the quality control of Imatinib Active Pharmaceutical Ingredient (API) to ensure product purity and safety.
• Preclinical and Clinical Development: A vital tool for supporting regulatory filings (e.g., IND, NDA) by characterizing the safety profile of drug metabolites.
• Synthetic Intermediate: Utilized in the chemical synthesis of novel Imatinib analogs and derivatives for structure-activity relationship (SAR) studies.
• Diagnostic Assay Development: Acts as a calibrator in the development of immunoassays or LC-MS/MS methods for therapeutic drug monitoring (TDM).

Basic Information

Product Name	n-Desmethyl Imatinib
CAS No.	1356565-46-2
Molecular Formula	C28H30N7O
Molecular Weight	480.59 g/mol
Synonyms	N-Desmethyl Imatinib; Imatinib N-Desmethyl Metabolite; CGP 74588; STI 571 Metabolite; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide; N-Desmethyl Gleevec; N-Desmethyl STI571; N-Desmethyl Imatinib Free Base
EINECS	Contact for details

Quality Control

Our n-Desmethyl Imatinib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identity confirmation via spectroscopic methods (NMR, MS). A detailed Certificate of Analysis (COA) is provided with every shipment, ensuring traceability and compliance with research-grade standards. We support development projects requiring custom purity specifications or GMP-grade material.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The compound is hygroscopic (moisture-sensitive); therefore, containers should be kept in a dry environment and allowed to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	< 20 ppm

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