Description

Imatinib Related Substance B is a high-purity reference standard and pharmaceutical intermediate critical for quality control and research in the development of targeted cancer therapies. This compound is essential for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Imatinib Mesylate. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in the development, validation, and production of oncology drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, assay, and impurity profiling of Imatinib Mesylate API in accordance with pharmacopeial monographs (USP, EP).
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity quantification and stability studies.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical quality control laboratories to monitor and control impurity levels to meet ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings for FDA, EMA, and other global health authorities.
• Process Chemistry Research: Used in research to study the synthesis pathway of Imatinib, helping to optimize manufacturing processes and minimize related substance formation.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation profile of the Imatinib API.

Basic Information

Product Name	Imatinib Related Substance B
CAS No.	571186-93-1
Molecular Formula	C29H31N7O
Molecular Weight	493.60 g/mol
Synonyms	4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide Impurity B; Imatinib Impurity B; STI-571 Related Substance B; Gleevec/Glivec Impurity B; N-[4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-4-[(4-methyl-1-piperazinyl)methyl]benzamide; CGP 57148B; Benzamide, 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-
EINECS	Contact for details

Quality Control

Our Imatinib Related Substance B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data and traceable results are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.