Description

Axitinib Impurity 2 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 and quality control. It is primarily used by researchers and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Axitinib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Axitinib API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Critical for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products in Axitinib formulations under various storage conditions.
• Process Chemistry Research: Used to study and optimize the synthesis and purification processes of Axitinib to minimize impurity formation.

Basic Information

Item	Detail
Product Name	Axitinib Impurity 2
CAS No.	1428728-83-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Axitinib Related Compound 2; Axitinib Impurity B; Axitinib EP Impurity B; Axitinib USP Impurity; 1H-Indazole-3-carboxamide, N-methyl-2-[[3-((1E)-2-(2-pyridinyl)ethenyl)-1H-indazol-6-yl]thio]-; (E)-N-methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1H-indazol-6-yl)thio)-1H-indazole-3-carboxamide
EINECS	Contact for details

Quality Control

Our Axitinib Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data, including HPLC purity and related substance profiles, are provided and traceable to a primary reference standard where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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