Description

Imatinib Impurity 72 is a designated impurity associated with the active pharmaceutical ingredient Imatinib, a key oncology drug. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes to ensure drug safety and efficacy. It is primarily used by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and compliance testing. Precise identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Imatinib and its related substances.
• Impurity Profiling: Essential for identifying, characterizing, and controlling impurities during the development and manufacturing of Imatinib API and finished dosage forms.
• Method Development & Validation: Serves as a critical component in developing and validating analytical methods, particularly HPLC, UPLC, and LC-MS techniques.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Used to track the formation of degradation products in stability testing of Imatinib drug products under various environmental conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug substance impurity profile.

Basic Information

Item	Details
Product Name	Imatinib Impurity 72
CAS No.	1821122-73-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Imatinib Related Compound 72; Imatinib EP Impurity I; Imatinib USP Impurity; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide Impurity; Gleevec Impurity; STI-571 Impurity; Imatinib Mesylate Impurity; CGP 57148B Impurity
EINECS	Contact for details

Quality Control

Every batch of Imatinib Impurity 72 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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