Description

Imatinib Impurity 31 is a designated impurity of the active pharmaceutical ingredient Imatinib, a key tyrosine kinase inhibitor. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification and quantification of this specific impurity. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development and validation in impurity profiling.
• Analytical Research: Used in HPLC, LC-MS, and other chromatographic studies for the identification and quantification of impurities in Imatinib API and finished drug products.
• Quality Control & Assurance: Critical for establishing and monitoring specification limits for impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation and levels of this impurity under various stress conditions and over the shelf life of the drug.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry R&D: Aids in the optimization of synthetic routes and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Imatinib Impurity 31
CAS No.	1356565-47-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Imatinib Related Compound 31; 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 31; Imatinib Mesylate Impurity 31
EINECS	Contact for details

Quality Control

Our Imatinib Impurity 31 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is supplied with each product, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 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.