Masitinib Mesylate is the mesylate salt of masitinib, a synthetic small-molecule tyrosine kinase inhibitor. It has been investigated for its activity against several kinases, including KIT, LYN, FYN and other tyrosine kinases involved in cellular signaling, proliferation and inflammatory responses.
Masitinib has been studied across several therapeutic areas, including oncology, inflammatory diseases and neurological disorders. Its kinase-inhibitory activity makes it a compound of interest for pharmaceutical research and formulation development.
Masitinib Mesylate is supplied as a pharmaceutical salt form of masitinib. The molecular formula is C28H35N5O4S·CH4O3S, with a molecular weight of approximately 649.78 g/mol.
The CAS Number for Masitinib Mesylate is 104807-07-4.
Masitinib inhibits selected tyrosine kinases involved in cellular signaling. Its principal pharmacological activity includes inhibition of KIT and other kinases such as LYN and FYN.
By inhibiting kinase-mediated signaling, masitinib can affect processes including cell proliferation, survival, activation and inflammatory mediator release. Its activity against mast-cell-associated signaling has also been an important area of investigation.
Masitinib Mesylate has been investigated for pharmaceutical applications involving oncology, inflammatory disorders and neurological diseases. Its development has included research into conditions where abnormal tyrosine kinase signaling or mast-cell activity may contribute to disease progression.
Specific therapeutic indications and regulatory status vary by jurisdiction and should be confirmed against current regulatory information.
Masitinib Mesylate API can be evaluated using validated analytical methods for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
HPLC and other validated chromatographic and spectroscopic techniques may be used for identity, assay and purity determination. Appropriate controls should be established for process-related impurities, degradation products and residual solvents.
Final acceptance criteria should be based on the applicable manufacturer's approved drug-substance specification and Certificate of Analysis.
Masitinib Mesylate should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. It should be protected from excessive heat, moisture and direct light.
Specific storage and transportation requirements should follow the applicable manufacturer's approved specification.
Masitinib Mesylate API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Masitinib Mesylate API is available for qualified pharmaceutical development and manufacturing requirements. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 3.0–5.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |
| Melting Point | Approximately 170–175 °C |