Eculizumab API
Eculizumab is a recombinant humanized monoclonal antibody that selectively binds to complement protein C5 (complement component 5). By inhibiting the cleavage of C5 into C5a and C5b, eculizumab prevents formation of the terminal complement complex and helps suppress complement-mediated tissue damage. (pubchem.ncbi.nlm.nih.gov)
Eculizumab API Manufacturer & Supplier
Eculizumab is a biological pharmaceutical ingredient used in the development and manufacture of complement-targeted therapies. It is a recombinant monoclonal antibody produced using mammalian-cell expression technology and requires specialized biological characterization and quality-control testing.
Key Information
| 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 |