Description

Axitinib Impurity A (CAS NO 1347304-18-0) is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities during the manufacturing of the active pharmaceutical ingredient (API) Axitinib. It is primarily used by analytical chemists and quality control professionals in pharmaceutical companies and contract research organizations (CROs) to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis of Axitinib.
• Impurity Profiling & Characterization: Used to identify and quantify this specific impurity in Axitinib drug substance and finished drug products to meet ICH Q3A/B guidelines.
• Quality Control & Assurance: Critical for routine batch release testing in API manufacturing to ensure impurity levels are within specified limits.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions to establish product shelf-life.
• Process Chemistry Research: Aids chemists in optimizing synthesis and purification steps to minimize the formation of this impurity.

Basic Information

Product Name	Axitinib Impurity A
CAS No.	1347304-18-0
Molecular Formula	C22H18N4OS
Molecular Weight	386.47 g/mol
Synonyms	N-Methyl-2-[[3-[(E)-2-pyridin-2-ylethenyl]-1H-indazol-6-yl]sulfanyl]benzamide; Axitinib Related Compound A; Axitinib Impurity 1; AG-013736 Impurity A; (E)-N-Methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1H-indazol-6-yl)thio)benzamide
EINECS	Contact for details

Quality Control

Every batch of Axitinib Impurity A is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data, including HPLC purity, related substance profiles, and structural confirmation (NMR, MS). A Certificate of Analysis (COA) detailing batch-specific results is supplied with each product, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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