Description

Imatinib Related Substance C is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Imatinib through rigorous analytical control. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and stability studies. The availability of this well-characterized related substance is fundamental to maintaining compliance with stringent global pharmacopeial standards.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Imatinib mesylate API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection and control strategies.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch release testing to monitor impurity levels and ensure product consistency against International Conference on Harmonisation (ICH) guidelines.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, humidity, light) as part of drug stability profiling.
• Regulatory Submissions: Provides essential data and characterization for regulatory filings (e.g., with the FDA, EMA) to demonstrate comprehensive impurity control.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this related substance during API synthesis.

Basic Information

Item	Detail
Product Name	Imatinib Related Substance C
CAS No.	938082-57-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Imatinib Impurity C; Imatinib Related Compound C; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide Related Substance C; Gleevec/Glivec Related Substance C; STI-571 Related Substance C; N-{5-[4-(4-Methylpiperazin-1-ylmethyl)benzoylamido]-2-methylphenyl}-4-(3-pyridyl)pyrimidin-2-amine Related Substance C
EINECS	Contact for details

Quality Control

Our Imatinib Related Substance C is manufactured and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including chromatographic purity, identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing all test results against established specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle with appropriate precautions in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.