Description

Imatinib Meta-Methyl-Piperazine Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of the active pharmaceutical ingredient Imatinib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method validation, impurity profiling, and ensuring regulatory compliance. The precise characterization of this impurity is essential for maintaining the safety and efficacy of the final drug product.

Application

• Pharmaceutical Impurity Reference Standard for the quality control of Imatinib API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, LC-MS) in regulatory filing and stability studies.
• Pharmacopoeial Testing to comply with USP, EP, or other pharmacopoeia monographs for Imatinib.
• Research and Development of synthetic pathways and degradation studies for tyrosine kinase inhibitors.
• Regulatory Compliance and Documentation for ANDA, NDA, and other regulatory submissions to agencies like the FDA and EMA.
• Calibration and Qualification of analytical instruments used in pharmaceutical quality assurance labs.

Basic Information

Product Name	Imatinib Meta-Methyl-Piperazine Impurity
CAS No.	1246819-59-9
Molecular Formula	C30H35N7O
Molecular Weight	509.65 g/mol
Synonyms	Imatinib m-Methylpiperazine Impurity; Imatinib N-Methylpiperazine Isomer; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide; Gleevec/Glivec Impurity; STI571 Meta-Methyl-Piperazine Impurity; Imatinib Mesylate Related Compound; N-(4-Methyl-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide isomer
EINECS	Contact for details

Quality Control

Our Imatinib Meta-Methyl-Piperazine Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and specifications. We support compliance with ICH Q3A/B guidelines and relevant pharmacopoeial requirements.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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