Description

Imatinib n-Acetyl Impurity is a specified organic compound used as a critical reference standard in pharmaceutical development and quality control. This impurity is essential for monitoring and controlling the purity of the active pharmaceutical ingredient (API) Imatinib Mesylate, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the research, production, and validation of anticancer medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of the n-Acetyl derivative in Imatinib Mesylate API batches.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS), for impurity profiling.
• Quality Assurance & Control (QA/QC): Critical for routine testing in pharmaceutical QC laboratories to ensure API purity meets pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity levels and characterization for drug master files.
• Stability Studies: Employed in forced degradation and long-term stability studies of Imatinib to understand degradation pathways and establish shelf-life.
• Research and Development: Used in synthetic chemistry R&D to study the formation, fate, and purge of this specific impurity during the API manufacturing process.

Basic Information

Product Name	Imatinib n-Acetyl Impurity
CAS No.	1321600-78-5
Molecular Formula	C30H35N7O2
Molecular Weight	525.65 g/mol
Synonyms	N-Acetyl Imatinib; Imatinib N-Acetylated Impurity; Imatinib Acetyl Impurity; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-benzamide, N-Acetyl Derivative; Gleevec n-Acetyl Impurity; STI571 n-Acetyl Impurity; Imatinib Related Compound C (in some references); N-[4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-4-[(4-methyl-1-piperazinyl)methyl]benzamide, N-Acetyl Analog
EINECS	Contact for details

Quality Control

Our Imatinib n-Acetyl Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference material. 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 at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly 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)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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