99% High Purity Cabozantinib Malate Pharmacy Grade Raw Power CAS 1140909-48-3

Cabozantinib Malate More Info

Chemical Profile and Structural Characteristics

Cabozantinib Malate (CAS 1140909-48-3) is the malate salt form of cabozantinib, a multi-targeted tyrosine kinase inhibitor. The compound features a quinoline core structure with strategic substituents that confer potent activity against multiple receptor tyrosine kinases including MET, VEGFR2, and AXL. The formation of the malate salt enhances the compound's aqueous solubility and bioavailability while maintaining the pharmacological profile of the parent molecule. It presents as a solid with defined crystalline properties and demonstrates optimal physicochemical characteristics for pharmaceutical development, including appropriate stability and dissolution properties.

Mechanism of Action and Pharmacological Activity

The compound exerts its antitumor effects through potent inhibition of multiple receptor tyrosine kinases involved in tumor pathogenesis and progression, with particular potency against MET, VEGFR2, RET, and AXL. By simultaneously blocking these key signaling pathways, cabozantinib malate disrupts critical tumor survival mechanisms including angiogenesis, invasion, metastasis, and drug resistance. This multi-targeted approach produces comprehensive antitumor activity across various malignancies, with the malate salt formation optimizing the pharmacokinetic profile to ensure sustained target coverage while maintaining the fundamental mechanism of action of the parent compound.

Therapeutic Applications and Clinical Uses

Cabozantinib malate is approved for the treatment of progressive, metastatic medullary thyroid cancer and advanced renal cell carcinoma following prior anti-angiogenic therapy. Clinical protocols typically initiate therapy at 60 mg administered orally once daily in fasting conditions, with dose adjustments based on individual tolerance and specific adverse effect management. The compound has demonstrated significant improvement in progression-free survival in multiple phase III trials across these indications, establishing its role as a standard therapeutic option. Additional approved applications include hepatocellular carcinoma in patients previously treated with sorafenib.

Formulation Development and Pharmaceutical Considerations

We supply cabozantinib malate active pharmaceutical ingredient suitable for the development of immediate-release oral formulations, primarily tablets. The malate salt form provides advantages in formulation development including enhanced dissolution characteristics and improved chemical stability compared to alternative salt forms. Our technical data includes comprehensive compatibility information with common pharmaceutical excipients, stability profiles under various storage conditions, and guidance on manufacturing processes to ensure robust product performance. Formulation strategies focus on achieving consistent bioavailability while maintaining the chemical integrity of the salt form throughout the product lifecycle.

Quality Specifications and Analytical Controls

Our cabozantinib malate meets stringent pharmacopeial standards with specifications including identification by chromatographic and spectroscopic methods, assay requirement of 98.0-102.0%, and of related substances and degradation products. Critical quality attributes encompass tests for residual solvents, heavy metals, microbial limits, and specific characterization of the salt form stoichiometry. We employ validated stability-indicating HPLC methods for precise quantification and impurity profiling, supported by mass spectrometric techniques for structural confirmation. Storage recommendations specify protection from light and moisture at controlled room temperature to ensure chemical stability throughout the product lifecycle.

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Company Profile

Established in 2013, Hyper Chem has exclusive tie-ups with leading manufacturers, supplying raw materials produced in GMP and ISO 9002 certified facilities, and provides high-quality ingredients and raw materials to cater to the requirements of our diverse range of clients.

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