General Information

Cabozantinib Impurities and Cabozantinib 

Daicel Pharma synthesizes Cabozantinib impurities of exceptional quality, such as Cabozantinib monohydroxy sulfate, Cabozantinib N-oxide, Cabozantinib amide cleavage product, CBT Dimer, CBT 2-fluoro, CBT 3-fluoro, and so on. These impurities are crucial to assess the purity, reliability, and safety of Cabozantinib, an active pharmaceutical ingredient. Besides, Daicel Pharma provides custom synthesis of Cabozantinib impurities to meet clients’ demands for delivery worldwide.

Cabozantinib [CAS: 849217-68-1] is a small molecule receptor tyrosine kinase (RTK) inhibitor that can fight cancer. This potent antineoplastic agent treats advanced forms of medullary thyroid cancer and renal cell carcinoma resistant to other treatments. Cabozantinib is a promising therapeutic option for patients with metastatic cancer.

Cabozantinib: Use and Commercial Availability  

Cabozantinib treats advanced cancer like metastatic medullary thyroid cancer and advanced renal cell carcinoma in patients previously undergone antiangiogenic therapy. Additionally, it is approved for use in patients with advanced hepatocellular carcinoma treated with sorafenib. Cabozantinib is available under two brand names: Cabometyx and Cometriq.

Cabozantinib Structure and Mechanism of Action

The chemical name of Cabozantinib is N′-[4-[(6,7-Dimethoxy-4-quinolinyl)oxy]phenyl]-N-(4-fluorophenyl)-1,1-cyclopropane dicarboxamide. Its chemical formula is C₂₈H₂₄FN₃O₅, and its molecular weight is approximately 501.5 g/mol.

Cabozantinib inhibits the tyrosine kinase activity of receptor tyrosine kinases. They inhibit tumor growth and lead to tumor regression.

Cabozantinib Impurities and Synthesis

During the manufacturing¹ of Cabozantinib, impurities form that can be unwanted or potentially harmful. It needs control to ensure the safety and efficacy of the final product. Cabozantinib impurities form through several reactions, like oxidation, hydrolysis, and photolysis. Methods such as process optimization, purification, and analytical testing help control and minimize the formation of impurities in Cabozantinib.

Daicel Pharma offers a Certificate of Analysis (CoA) for Cabozantinib impurity standards, such as Cabozantinib monohydroxy sulfate, Cabozantinib N-oxide, Cabozantinib amide cleavage product, CBT Dimer, CBT 2-fluoro, CBT 3-fluoro, and so on, generated from an analytical facility compliant with cGMP standards. The CoA includes a comprehensive characterization report comprising data from techniques like 1H NMR, 13C NMR, IR, MASS, and HPLC purity. Furthermore, on request, we can provide additional data like 13C-DEPT and CHN. Daicel Pharma can synthesize unknown Cabozantinib impurities or degradation products². A complete characterization report accompanies every delivery.