Description

Axitinib Impurity 4 is a specified impurity of the active pharmaceutical ingredient Axitinib, a tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical reference materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Axitinib drug substance and finished products.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles during API synthesis.
• Quality Control & Assurance: Employed in routine QC testing to ensure Axitinib batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Axitinib Impurity 4
CAS No.	1443118-73-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Axitinib Related Compound 4; Axitinib Impurity D; Axitinib EP Impurity D; Axitinib USP Impurity; N-Methyl-2-[[3-((E)-2-pyridin-2-ylethenyl)-1H-indazol-6-yl]sulfanyl]benzamide (Common Name); Axitinib Process Impurity; Axitinib Degradant
EINECS	Contact for details

Quality Control

Every batch of Axitinib Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry and research standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use as reference standards in regulated 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). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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