Description

Imatinib Impurity CAS NO 475587-23-6 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Imatinib Mesylate. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for companies producing or testing generic oncology medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Imatinib Mesylate API and finished dosage forms.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurity profiles in accordance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product purity meets pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation and levels of degradation products under various stress conditions (e.g., heat, humidity, light) during drug shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, DMF) to demonstrate comprehensive impurity characterization and control strategies.
• Research and Development: Supports process chemistry research to understand and minimize impurity formation during the synthesis of Imatinib.

Basic Information

Product Name	Imatinib Impurity
CAS No.	475587-23-6
Molecular Formula	C29H31N7O
Molecular Weight	493.60 g/mol
Synonyms	Imatinib Related Compound; Imatinib Mesylate Impurity; N-(4-Methyl-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide; Gleevec Impurity; STI-571 Impurity; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide; Benzamide, N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-4-[(4-methyl-1-piperazinyl)methyl]-
EINECS	Contact for details

Quality Control

Every batch of Imatinib Impurity (CAS 475587-23-6) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, and residual solvents, supporting compliance with ICH Q3A(R2) and Q3B(R2) guidelines for impurities.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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