Description

Nilotinib Hydrochloride Monohydrate CAS NO 923288-90-8 is a high-purity, small-molecule active pharmaceutical ingredient (API) used as a tyrosine kinase inhibitor. This compound is critical for the research, development, and manufacturing of targeted cancer therapies, particularly for chronic myeloid leukemia (CML). It is essential for pharmaceutical companies, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in oncology drug development and generic API production.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of targeted cancer therapeutics.
• Oncology Research: Key reference standard and biochemical tool for studying BCR-ABL tyrosine kinase inhibition mechanisms.
• Drug Development: Used in preclinical and clinical development stages for new anti-cancer formulations and combination therapies.
• Generic Drug Manufacturing: Sourcing of the API for the production of generic versions of tyrosine kinase inhibitor medications.
• Analytical Standard: Serves as a high-purity standard for quality control (QC) and analytical method development (HPLC, LC-MS).
• Biopharmaceutical Intermediates: Used in the synthesis of more complex drug conjugates or prodrugs.

Basic Information

Product Name	Nilotinib Hydrochloride Monohydrate
CAS No.	923288-90-8
Molecular Formula	C28H22F3N7O • HCl • H2O
Molecular Weight	584.0 g/mol (monohydrate)
Synonyms	Nilotinib HCl monohydrate; AMN-107 Hydrochloride Monohydrate; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide hydrochloride monohydrate; Tasigna® API; Nilotinib monohydrochloride monohydrate; UNII-8BQ45424VY
EINECS	Contact for details

Quality Control

Our Nilotinib Hydrochloride Monohydrate is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical research and development. Comprehensive testing includes identity confirmation, assay (HPLC), and control of specified impurities and residual solvents. A Certificate of Analysis (COA) documenting compliance with in-house specifications is provided with every shipment.

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 in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

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% (on anhydrous basis)
Water Content (KF)	2.5% - 4.5%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm

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