Description

Tucatinib is a potent and highly selective small-molecule tyrosine kinase inhibitor (TKI) targeting HER2. This compound matters significantly as a key active pharmaceutical ingredient (API) in targeted cancer therapies, offering a crucial treatment pathway for patients with specific HER2-positive malignancies. It is primarily needed by pharmaceutical manufacturers and research institutions engaged in the development and production of innovative oncology drugs, particularly for breast cancer and other solid tumors. Tucatinib CAS NO 937263-43-9 represents a critical component in the advancement of precision medicine.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the formulation of targeted oral anti-cancer medications.
• Clinical and preclinical research and development for HER2-positive cancers, including metastatic breast cancer and colorectal cancer.
• Manufacturing of finished dosage forms, such as tablets, for commercial pharmaceutical products.
• Use as a reference standard in analytical laboratories for quality control and method development.
• Biochemical research focusing on HER2 signaling pathways and mechanisms of drug resistance.
• Investigation in combination therapies with other chemotherapeutic agents or monoclonal antibodies.

Basic Information

Product Name	Tucatinib
CAS No.	937263-43-9
Molecular Formula	C26H24N8O2
Molecular Weight	480.52 g/mol
Synonyms	ARRY-380; ONT-380; IKU-1576; 6,6-Dimethyl-9-[4-(4-methylpiperazin-1-yl)methyl]phenyl]-8,9,10,11-tetrahydro-7H-pyrido[4',3':4,5]pyrrolo[3,2-f]quinazolin-2-amine; Tucatinibum; Tukysa (brand name); TKI Tucatinib
EINECS	Contact for details

Quality Control

Our Tucatinib is manufactured under strict quality management systems to ensure it meets the high-purity standards required for pharmaceutical applications. Each batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, residual solvent analysis (GC), and identification (IR, MS). Certificates of Analysis (COA) detailing all specifications and test results are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤0.5%
Heavy Metals	≤20 ppm

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