Description

Bosutinib Monohydrate is a potent and selective small-molecule tyrosine kinase inhibitor primarily targeting the Bcr-Abl and Src family kinases. This compound is of significant commercial and research interest for its therapeutic potential in oncology. It is essential for pharmaceutical R&D, process development, and the production of active pharmaceutical ingredients (APIs). Bosutinib Monohydrate CAS NO 918639-08-4 is supplied to meet the stringent requirements of the global life sciences industry.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of targeted cancer therapeutics, specifically for the treatment of chronic myeloid leukemia (CML).
• Biomedical Research: Critical reference standard and biochemical tool for studying Bcr-Abl and Src kinase signaling pathways in cellular and in-vitro assays.
• Process Development & Scale-Up: Serves as a key intermediate and final product in the development and optimization of synthetic routes for commercial API manufacturing.
• Analytical & Quality Control: Used as a high-purity standard for method development, validation, and routine quality testing in analytical laboratories.
• Preclinical Studies: Employed in pharmacokinetic, pharmacodynamic, and toxicology studies to support regulatory filings and clinical trials.
• Custom Synthesis & Contract Manufacturing: Available for custom synthesis projects to support drug discovery and development programs.

Basic Information

Product Name	Bosutinib Monohydrate
CAS No.	918639-08-4
Molecular Formula	C₂₆H₂₉Cl₂N₅O₃ • H₂O
Molecular Weight	548.46 g/mol (Anhydrous: 530.45 g/mol)
Synonyms	SKI-606 Monohydrate; 4-[(2,4-Dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile Monohydrate; Bosutinib Hydrate; Bosulif (trade name) Monohydrate; UNII-5018V4AEZ0 (monohydrate)
EINECS	Contact for details

Quality Control

Our Bosutinib Monohydrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting or exceeding typical pharmaceutical-grade specifications. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to support your quality and 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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.0% (on anhydrous basis)
Water Content (KF)	3.0% - 5.0%
Related Substances (HPLC)	Total impurities ≤2.0%; Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm
Residue on Ignition	≤0.1%

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