Description

Imatinib Impurity 4 is a designated impurity associated with the active pharmaceutical ingredient Imatinib Mesylate, a key oncology drug. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in the development and production of generic or branded Imatinib formulations. Ensuring the identity and quantification of this impurity is essential for meeting stringent regulatory requirements for drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Imatinib Impurity 4 in drug substance and drug product testing.
• Analytical Method Development: Used in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Imatinib.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization.
• Research & Development: Utilized in pharmaceutical R&D for studying the synthesis, metabolism, and pharmacokinetics of Imatinib and related compounds.

Basic Information

Product Name	Imatinib Impurity 4
CAS No.	942514-62-7
Molecular Formula	C29H31N7O
Molecular Weight	493.60 g/mol
Synonyms	4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide Impurity 4; Imatinib Related Compound 4; Gleevec Impurity 4; STI571 Impurity 4; N-{4-Methyl-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]phenyl}-4-[(4-methylpiperazin-1-yl)methyl]benzamide Impurity; Bcr-Abl Inhibitor Impurity 4
EINECS	Contact for details

Quality Control

Our Imatinib Impurity 4 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including HPLC purity, related substances, residual solvents, and spectroscopic identification (IR, NMR, MS). We support compliance with ICH guidelines and relevant pharmacopeial standards, making this material suitable for GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under appropriate conditions to prevent degradation.

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)	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.