Description

Axitinib Impurity D is a specified impurity of the active pharmaceutical ingredient Axitinib, a tyrosine kinase inhibitor used in cancer therapy. 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: Primary use 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 other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing within pharmaceutical quality control laboratories to ensure API and drug product specifications are met.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions.
• Research & Development: Used by chemists in process chemistry to understand and control impurity formation during the synthesis of Axitinib.

Basic Information

Product Name	Axitinib Impurity D
CAS No.	1443118-72-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Axitinib Related Compound D; Axitinib Impurity 4; Axitinib EP Impurity D; Axitinib USP Impurity D; AG-013736 Impurity D; N-Methyl-2-[[3-((E)-2-pyridin-2-ylethenyl)-1H-indazol-6-yl]sulfanyl]benzamide (Common IUPAC-based name); Axitinib Specified Impurity D
EINECS	Contact for details

Quality Control

Our Axitinib Impurity D is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards are designed to meet the stringent requirements of pharmaceutical reference material applications, supporting compliance with ICH, USP, and EP guidelines.

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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