Description

Dasatinib Monohydrate is a potent and selective small molecule tyrosine kinase inhibitor, widely recognized for its therapeutic applications. This high-purity active pharmaceutical ingredient (API) is critical for pharmaceutical development and manufacturing, ensuring efficacy and safety in final drug products. It is primarily utilized by pharmaceutical companies and research institutions engaged in oncology drug development and advanced biomedical research.

Application

• Pharmaceutical API: Serves as the active pharmaceutical ingredient in the formulation of targeted cancer therapies.
• Oncology Research: Used as a key reference standard and biochemical tool in cancer research, particularly for studying BCR-ABL and SRC family kinases.
• Drug Development: Employed in preclinical and clinical development stages for new therapeutic entities targeting specific tyrosine kinases.
• Biochemical Assays: Functions as a specific inhibitor in enzymatic and cellular assays to elucidate signaling pathways.
• Reference Standard: Used in quality control laboratories for the identification and assay of drug substances and products via HPLC and other analytical methods.
• Academic & Institutional Research: Supports basic scientific research in universities and institutes focusing on cell proliferation and signal transduction.

Basic Information

Product Name	Dasatinib Monohydrate
CAS No.	863127-77-9
Molecular Formula	C₂₂H₂₆ClN₇O₂S • H₂O
Molecular Weight	506.02 g/mol (Monohydrate)
Synonyms	BMS-354825 Monohydrate; Dasatinib Hydrate; Sprycel® (Brand Name); N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide Monohydrate; SRC/ABL Inhibitor; Dasatinib (Anhydrous Basis)
EINECS	Contact for details

Quality Control

Our Dasatinib Monohydrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. Certificates of Analysis (COA) documenting compliance with relevant standards are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.0% - 5.0%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
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.