Description

Imatinib Impurity CAS NO 152459-96-6 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Imatinib Mesylate, a key oncology drug. Pharmaceutical manufacturers and analytical laboratories rely on this impurity standard to ensure drug safety, efficacy, and regulatory compliance. Its precise identification and quantification are fundamental to meeting stringent pharmacopeial requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Imatinib Mesylate API batches.
• Method Development & Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products during forced degradation and long-term stability testing of Imatinib drug products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity during API manufacturing.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure product purity and safety.

Basic Information

Product Name	Imatinib Impurity
CAS No.	152459-96-6
Molecular Formula	C29H31N7O
Molecular Weight	493.60 g/mol
Synonyms	N-{5-[4-(4-Methylpiperazin-1-yl)methyl]benzoyl}-2-methylbenzene-1,4-diamine; Imatinib Related Compound; STI-571 Impurity; Gleevec Impurity; Imatinib Free Base Impurity; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide Impurity; Benzamide, 4-((4-methyl-1-piperazinyl)methyl)-N-(4-methyl-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)phenyl)-
EINECS	Contact for details

Quality Control

Every batch of Imatinib Impurity (CAS 152459-96-6) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and research needs.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if prolonged storage is required.

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)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0% 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.