Description

Imatinib Impurity 7 is a specified impurity associated with the active pharmaceutical ingredient (API) Imatinib Mesylate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories to ensure the purity, safety, and efficacy of Imatinib-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Imatinib Mesylate API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in batch release testing to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Imatinib formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Imatinib Impurity 7
CAS No.	581076-64-4
Molecular Formula	C29H31N7O
Molecular Weight	493.60 g/mol
Synonyms	N-[4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-4-[(4-methyl-1-piperazinyl)methyl]benzamide; Imatinib N-Oxide Impurity; Gleevec Impurity 7; STI571 Impurity 7; Imatinib Related Compound 7; 4-[(4-Methylpiperazin-1-yl)methyl]-N-[4-methyl-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]phenyl]benzamide; N-(4-Methyl-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide
EINECS	Contact for details

Quality Control

Every batch of Imatinib Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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