Encorafenib API is a synthetic, small-molecule BRAF kinase inhibitor used in the development and manufacture of targeted anticancer pharmaceutical formulations. It selectively inhibits BRAF kinase, including BRAF V600E, a mutated form of the BRAF protein associated with abnormal cell signaling and tumor growth.
Encorafenib is approved in combination with binimetinib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. It is also used in combination with cetuximab for certain patients with metastatic colorectal cancer containing a BRAF V600E mutation.
Encorafenib is a potent and selective BRAF inhibitor belonging to the targeted therapy class of anticancer medicines. By inhibiting mutated BRAF signaling, Encorafenib can interfere with the MAPK signaling pathway involved in cancer-cell proliferation.
Encorafenib has the molecular formula C₂₂H₂₇ClFN₇O₄S and a molecular weight of approximately 540.02 g/mol. Its CAS number is 1269440-17-6.
Swapnroop Drugs and Pharmaceuticals provides Encorafenib API for qualified pharmaceutical manufacturing, formulation development, research and pharmaceutical sourcing requirements.
Encorafenib is a specialized oncology API suitable for pharmaceutical companies and formulation developers working with BRAF-targeted therapies.
Encorafenib selectively inhibits BRAF kinase. BRAF is part of the RAS/RAF/MEK/ERK signaling pathway, which regulates cell growth and proliferation. In tumors containing activating BRAF mutations, this pathway can become abnormally active. Encorafenib inhibits BRAF signaling and helps suppress downstream pathway activity.
Encorafenib is associated with pharmaceutical applications involving:
Encorafenib API can be evaluated using validated analytical procedures for identity, assay, related substances, residual solvents, water content, elemental impurities and other applicable quality attributes.
Numerical acceptance criteria should be taken from the current approved manufacturer specification, COA or applicable pharmacopoeial/regulatory documentation rather than using generic limits.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |