Description

Imatinib Impurity 2 is a designated impurity associated with the active pharmaceutical ingredient Imatinib, a key tyrosine kinase inhibitor. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily utilized by analytical laboratories, quality assurance departments, and R&D teams within the global pharmaceutical and biotechnology sectors for method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Imatinib mesylate and related drug substances.
• Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to accurately identify and quantify this specific impurity.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels, ensuring drug substance and product meet stringent pharmacopeial (USP, EP) and ICH guidelines.
• Stability Studies: Employed to track the formation and growth of impurities over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Imatinib, helping to improve formulation and storage conditions.

Basic Information

Item	Detail
Product Name	Imatinib Impurity 2
CAS No.	1384131-91-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Imatinib Related Compound 2; Imatinib Impurity B; Imatinib EP Impurity B; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide Impurity; Gleevec Impurity 2; STI571 Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Imatinib Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, and NMR to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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