Also known as: HuMax-CD20; Arzerra; Kesimpta
Ofatumumab is a high-purity Active Pharmaceutical Ingredient (API) classified as a Anti-CD20 Monoclonal Antibody / Antineoplastic. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: 679818-59-8.
| Parameter | Specification |
|---|---|
| CAS Number | 679818-59-8 |
| Molecular Formula | Monoclonal antibody |
| Molecular Weight | ~149 kDa |
| Grade | IP / BP / EP / USP |
| Category | Anti-CD20 Monoclonal Antibody / Antineoplastic |
| Appearance | Clear to slightly opalescent, colorless to slightly yellow solution/powder |
| Solubility | Soluble in aqueous buffer (pH 6.5); stable in isotonic conditions |
| Assay | NLT 98.0% |
| Loss on Drying | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Residue on Ignition | NMT 0.1% |
| Microbial Limits | Complies with pharmacopoeia |
| Identification | IR, HPLC Compliant |
| Mfg Date | MAR 2026 |
| Exp Date | FEB 2031 |
| Packing | 25 kg HDPE drums / as per requirement |