Description

Imatinib Imidazole Impurity is a designated pharmaceutical impurity used in the quality control and analytical development of the active pharmaceutical ingredient (API) Imatinib Mesylate. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a reference standard for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, validation, and routine testing of Imatinib-based formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the imidazole-related impurity in Imatinib Mesylate API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC/UPLC methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure impurity levels are within International Council for Harmonisation (ICH) specified limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data required by agencies like the FDA and EMA.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation pathways in Imatinib formulations.
• Research & Process Chemistry: Used in research to understand the synthesis pathway of Imatinib and to optimize manufacturing processes to minimize this specific impurity.

Basic Information

Item	Details
Product Name	Imatinib Imidazole Impurity
CAS No.	1256080-10-0
Molecular Formula	C29H31N7O
Molecular Weight	493.60 g/mol
Synonyms	Imatinib Impurity 7; Imatinib Related Compound 7; Imatinib Imidazole Analog; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-imidazolyl]amino]phenyl]benzamide; Gleevec Imidazole Impurity; STI571 Imidazole Impurity; Imatinib Mesylate Imidazole Impurity
EINECS	Contact for details

Quality Control

Our Imatinib Imidazole Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure the highest standards of purity and identity. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for purity (by HPLC), identity (by IR, MS, NMR), and related substances. Our quality commitment aligns with the requirements for pharmaceutical reference standards, supporting compliance with ICH Q3A(R2), Q3B(R2) guidelines, and current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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