Flupirtine Maleate API is the maleate salt of flupirtine, an aminopyridine derivative. It is identified by CAS Number 75507-68-5, with the molecular formula C₁₉H₂₁FN₄O₆ and molecular weight 420.39 g/mol.
Flupirtine Maleate is chemically identified as ethyl N-[2-amino-6-[(4-fluorophenyl)methylamino]pyridin-3-yl]carbamate maleate. It is available as a crystalline solid and is commercially supplied as the maleate salt.
Flupirtine Maleate has a molecular formula of C₁₉H₂₁FN₄O₆, molecular weight 420.39 g/mol, and CAS Number 75507-68-5. The compound contains flupirtine and maleic acid in a 1:1 salt ratio.
Flupirtine Maleate is reported as a crystalline solid. TCI specifies a purity of >98.0% by HPLC, while other analytical suppliers report higher batch-specific purities depending on the material supplied.
For pharmaceutical-quality material, testing may include identification, HPLC assay, related substances, water content, loss on drying, residue on ignition and other applicable quality-control parameters. The exact specification should correspond to the approved manufacturer specification and batch CoA.
Flupirtine Maleate has been used as a pharmaceutical active ingredient and is associated with analgesic and muscle-relaxant activity. It has also been extensively studied in pharmaceutical and analytical research.
Flupirtine Maleate API can be supplied for pharmaceutical research, development and manufacturing applications subject to applicable regulatory and quality requirements. Batch-specific quality should be confirmed through the relevant Certificate of Analysis.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Melting Point | 183 – 187°C |