Description

Nilotinib Hydrochloride Anhydrous CAS NO 923288-95-3 is a high-purity, small molecule pharmaceutical intermediate and active pharmaceutical ingredient (API). This compound is a potent and selective tyrosine kinase inhibitor, crucial for advanced pharmaceutical research and development. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions engaged in oncology drug development and formulation studies.

Application

• Pharmaceutical API Synthesis: Serves as the active pharmaceutical ingredient in the manufacture of targeted cancer therapies.
• Oncology Research: Used as a critical reference standard and biochemical tool in cancer research, particularly for studying chronic myeloid leukemia (CML).
• Formulation Development: Employed in the development of solid dosage forms (e.g., tablets, capsules) and other drug delivery systems.
• Analytical Method Development: Acts as a primary standard for HPLC, LC-MS, and other analytical techniques to ensure quality control.
• Preclinical Studies: Utilized in pharmacokinetic, pharmacodynamic, and toxicology studies during drug discovery.
• Generic Drug Manufacturing: A key component for companies developing generic versions of tyrosine kinase inhibitor medications.

Basic Information

Product Name	Nilotinib Hydrochloride Anhydrous
CAS No.	923288-95-3
Molecular Formula	C28H22F3N7O · HCl
Molecular Weight	584.0 g/mol (as hydrochloride salt)
Synonyms	Nilotinib HCl; Nilotinib Hydrochloride; AMN-107 Hydrochloride; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide Hydrochloride; Tasigna® (brand name) API; UNII-6R7E5G8Y6I; BCR-ABL Tyrosine Kinase Inhibitor
EINECS	Contact for details

Quality Control

Our Nilotinib Hydrochloride Anhydrous is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided with every shipment. We adhere to cGMP principles where applicable to support our clients' regulatory requirements.

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 must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere such as nitrogen or argon to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0% (anhydrous basis)
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Total impurities ≤2.0%; Any single impurity ≤0.5%

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