Description

Imatinib Mesylate is a small molecule tyrosine kinase inhibitor of significant pharmaceutical importance. It is the active pharmaceutical ingredient (API) in targeted cancer therapies, primarily used to treat certain leukemias and gastrointestinal stromal tumors. This high-purity compound is essential for pharmaceutical manufacturers and research institutions developing and producing innovative oncology treatments. Its efficacy is directly linked to stringent quality and purity standards.

Application

• Pharmaceutical API: Primary use as the active ingredient in finished dosage forms for targeted cancer therapy.
• Chronic Myeloid Leukemia (CML) Treatment: Key component in medications for Philadelphia chromosome-positive CML.
• Gastrointestinal Stromal Tumors (GIST) Treatment: Used in therapies for KIT (CD117)-positive unresectable and/or metastatic GIST.
• Pharmaceutical Research & Development: Serves as a reference standard and building block in preclinical and clinical oncology research.
• Generic Drug Manufacturing: Critical for the production of bioequivalent generic versions of originator drugs.
• Formulation Development: Used in the development of various drug delivery systems, including tablets and capsules.

Basic Information

Item	Detail
Product Name	Imatinib Mesylate
CAS No.	220127-57-1
Molecular Formula	C29H31N7O · CH4O3S
Molecular Weight	589.71 g/mol
Synonyms	Imatinib Mesylate; STI571 Mesylate; CGP 57148B; Glivec (Trade Name); Gleevec (Trade Name); 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide methanesulfonate; Imatinib methanesulfonate
EINECS	Contact for details

Quality Control

Our Imatinib Mesylate is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and strength. We provide full traceability and support regulatory filings with detailed documentation. Certificates of Analysis (COA) are available for every batch, confirming compliance with in-house specifications and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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