Description

Imatinib Impurity 17 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Imatinib Mesylate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The precise characterization of this impurity is essential for method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Imatinib Mesylate API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor impurity profiles and degradation pathways of Imatinib under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the fate of related substances in biological systems.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure product purity meets pharmacopeial specifications (USP, EP).

Basic Information

Product Name	Imatinib Impurity 17
CAS No.	1802325-93-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-{5-[4-(4-Methylpiperazin-1-yl)methyl]benzoyl}-2-methyl-5-nitroaniline; Imatinib Nitro Impurity; Gleevec Impurity 17; STI571 Impurity 17; Imatinib Related Compound 17; 4'-[(4-Methyl-1-piperazinyl)methyl]-[1,1'-biphenyl]-3-carboxamide, N-(2-methyl-5-nitrophenyl)-; Imatinib Nitro Analog
EINECS	Contact for details

Quality Control

Our Imatinib Impurity 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with high-grade reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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