Description

Axitinib Impurity 27 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Axitinib, a tyrosine kinase inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Axitinib API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of Axitinib batches to meet pharmacopeial (USP, EP) and ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of this impurity under various stress conditions to determine drug shelf-life.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Axitinib.

Basic Information

Product Name	Axitinib Impurity 27
CAS No.	1639137-80-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Axitinib Related Compound 27; Axitinib EP Impurity 27; Axitinib USP Impurity 27; Axitinib Process Impurity 27; Axitinib Degradant 27; 1639137-80-6; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Axitinib Impurity 27 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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