Description

Imatinib Impurity K is a designated pharmaceutical impurity used as a critical reference standard in the development and quality control of the active pharmaceutical ingredient (API) Imatinib Mesylate. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and testing of oncology medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Imatinib Impurity K in Imatinib Mesylate API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in process chemistry to understand and control the formation pathways of this impurity during API synthesis.

Basic Information

Product Name	Imatinib Impurity K
CAS No.	2410195-20-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Imatinib Related Compound K; Imatinib EP Impurity K; Imatinib Mesylate Impurity K; Gleevec Impurity K; STI-571 Impurity K; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide Impurity K; Nilotinib Impurity K (by structure similarity); Benzamide impurity of Imatinib
EINECS	Contact for details

Quality Control

Our Imatinib Impurity K is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay. Our quality commitment aligns with the requirements of pharmaceutical compendia and ICH guidelines.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.