Also known as: IGE-025; Xolair; rhuMAb-E25
Omalizumab is a high-purity Active Pharmaceutical Ingredient (API) classified as a Anti-IgE Monoclonal Antibody / Anti-allergic. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: 242138-07-4.
| Parameter | Specification |
|---|---|
| CAS Number | 242138-07-4 |
| Molecular Formula | Humanized monoclonal antibody |
| Molecular Weight | ~149 kDa |
| Grade | IP / BP / EP / USP |
| Category | Anti-IgE Monoclonal Antibody / Anti-allergic |
| Appearance | White to off-white lyophilized powder |
| Solubility | Soluble in sterile water for injection; stable lyophilized powder |
| 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 |