Description

Nilotinib n-Oxide CAS NO 1246817-85-5 is a significant oxidative metabolite of the tyrosine kinase inhibitor nilotinib. This compound is of critical importance in pharmaceutical research and development, particularly for metabolic profiling, pharmacokinetic studies, and the synthesis of reference standards. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development, impurity characterization, and bioanalytical method validation for oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of nilotinib and its related substances in drug substances and products.
• Metabolite Identification & Profiling: Essential for in vitro and in vivo studies to understand the metabolic pathways and clearance mechanisms of nilotinib.
• Impurity Synthesis & Characterization: Serves as a key impurity standard for method development and validation, ensuring drug product safety and compliance with ICH Q3A/B guidelines.
• Bioanalytical Research: Employed in the development and validation of LC-MS/MS and HPLC methods for the accurate quantification of nilotinib and its metabolites in biological matrices.
• Preclinical & Clinical Research: Supports toxicology and pharmacokinetic studies to assess the safety and efficacy profile of nilotinib therapy.
• Process Chemistry & Scale-up: Used in the development and optimization of synthetic routes for nilotinib, helping to control and identify process-related impurities.

Basic Information

Product Name	Nilotinib n-Oxide
CAS No.	1246817-85-5
Molecular Formula	C28H22F3N7O2
Molecular Weight	545.52 g/mol
Synonyms	Nilotinib N-Oxide; Nilotinib Metabolite M11; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide N-Oxide; AMN107 N-Oxide; Tasigna N-Oxide; Nilotinib Impurity; Nilotinib Related Compound
EINECS	Contact for details

Quality Control

Our Nilotinib n-Oxide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and identity confirmation. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, meeting the stringent requirements for pharmaceutical reference standards and research chemicals.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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