Description

Nilotinib is a potent and selective small-molecule tyrosine kinase inhibitor. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of targeted cancer therapies. It is primarily required by pharmaceutical companies and advanced research institutions engaged in oncology drug development and production.

Application

• Active Pharmaceutical Ingredient (API) in the manufacture of targeted cancer therapeutics.
• Key intermediate in pharmaceutical research for chronic myeloid leukemia (CML) treatment.
• Reference standard for analytical method development and validation in quality control laboratories.
• Biochemical research tool for studying Bcr-Abl tyrosine kinase inhibition mechanisms.
• Pre-clinical and clinical trial material for novel oncology drug formulations.

Basic Information

Product Name	Nilotinib
CAS No.	641571-10-0
Molecular Formula	C28H22F3N7O
Molecular Weight	529.52 g/mol
Synonyms	AMN-107; Nilotinib Hydrochloride Monohydrate; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide; Tasigna (brand name); Nilotinib free base; Bcr-Abl tyrosine kinase inhibitor AMN107
EINECS	Contact for details

Quality Control

Our Nilotinib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by spectroscopic methods, to ensure compliance with ICH guidelines and relevant pharmacopeial standards. A detailed Certificate of Analysis (COA) is provided with every shipment to guarantee traceability and consistent quality.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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