Description

Axitinib Impurity Imyf is a high-purity reference standard used in the analytical characterization and quality control of the active pharmaceutical ingredient (API) Axitinib. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/control (QA/QC) units, and regulatory affairs departments involved in the development and manufacturing of oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Axitinib Impurity Imyf in Axitinib API and finished drug products.
• Method Development and Validation: Used in developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand impurity formation pathways.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to regulatory bodies like the FDA and EMA.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes by tracking the formation and removal of this specific impurity.

Basic Information

Product Name	Axitinib Impurity Imyf
CAS No.	1443118-71-5
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 Imyf; Axitinib Impurity F; UNII-9J8U3S6Z4P; Axitinib EP Impurity F; Axitinib USP Impurity F; Axitinib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Axitinib Impurity Imyf is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability information.

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. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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