Description

Imatinib Impurity CAS NO 1232063-00-1 is a high-purity reference standard critical for ensuring the quality and safety of the active pharmaceutical ingredient (API) Imatinib Mesylate. This compound is essential for pharmaceutical research, development, and quality control laboratories to identify, quantify, and monitor this specific impurity during manufacturing. It is primarily used by professionals in the pharmaceutical and biotechnology industries for method validation, stability studies, and regulatory compliance. The availability of a well-characterized impurity standard is fundamental to meeting stringent pharmacopeial requirements for drug substance purity.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Imatinib Mesylate drug substance and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Batch Release Testing: Essential for routine QC testing in API manufacturing to ensure batches comply with internal specifications and pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Submissions: Provides necessary data and reference samples for regulatory filings (e.g., FDA, EMA) to establish impurity acceptance criteria.
• Research and Development: Used in synthetic chemistry R&D to understand impurity formation pathways and optimize synthesis processes to minimize its presence.

Basic Information

Product Name	Imatinib Impurity
CAS No.	1232063-00-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Imatinib Related Compound; Imatinib Mesylate Impurity; Imatinib Process Impurity; Gleevec Impurity; STI-571 Impurity; 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide Impurity; Nilotinib Impurity (structural analog); Tyrosine Kinase Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Imatinib Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) containing batch-specific data on purity, impurities, and spectroscopic characterization (e.g., NMR, MS, IR). Our quality commitment aligns with ICH guidelines and supports compliance in cGMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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