Description

Imatinib Impurity M is a designated impurity of the active pharmaceutical ingredient Imatinib, a key tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the production and testing of Imatinib and its related drug substances.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity M in Imatinib drug substance and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) to separate and analyze impurities.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Used to track the formation and levels of this specific impurity under various stress conditions.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification of Imatinib.

Basic Information

Product Name	Imatinib Impurity M
CAS No.	1407229-73-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Imatinib Related Compound M; Imatinib EP Impurity M; Imatinib USP Impurity M; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide Impurity; Gleevec Impurity M; STI-571 Impurity M; Imatinib Mesylate Impurity M
EINECS	Contact for details

Quality Control

Our Imatinib Impurity M is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data on purity, impurities, and chromatographic profiles. Our quality commitment aligns with the requirements for pharmaceutical impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. 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 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.