Description

Axitinib Impurity C is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Axitinib by serving as a known impurity marker. It is essential for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and quality control processes. The precise characterization of this impurity is fundamental to meeting stringent pharmacopeial and regulatory requirements for drug substance and product release.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Axitinib API and finished drug products.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles during manufacturing.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Axitinib meets specified purity limits as per ICH Q3A/B guidelines.
• Stability Studies: Employed to track impurity formation and degradation pathways in stability testing of Axitinib under various conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of process-related impurities.

Basic Information

Product Name	Axitinib Impurity C
CAS No.	885126-40-9
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 C; Axitinib Impurity 3; AG-013736 Impurity C; (E)-N-Methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1H-indazol-6-yl)thio)benzamide; Axitinib Process Impurity; UNII-7W8V1K3C0I
EINECS	Contact for details

Quality Control

Every batch of Axitinib Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use as a high-purity reference standard for regulatory and QC applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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