Firmonertinib API is a selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) used in the development and treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Firmonertinib is also known by synonyms including Furmonertinib, Alflutinib, AST-2818 and AST2818.
Firmonertinib is a synthetic small-molecule compound designed to target mutant EGFR signaling. It has demonstrated activity against activating EGFR mutations and the acquired EGFR T790M resistance mutation.
The active moiety has the molecular formula C₂₈H₃₁F₃N₈O₂ and a molecular weight of approximately 568.59 g/mol. Firmonertinib is achiral and has no defined stereocenters.
Firmonertinib Mesylate is the mesylate salt form of firmonertinib. It has the molecular formula C₂₉H₃₅F₃N₈O₅S and molecular weight 664.70 g/mol.
Note: Firmonertinib is approved and commercially distributed in China, while it is not FDA-approved for any use in the United States as of the latest available information.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| 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% |