Also known as: Krystexxa; PEG-uricase
Pegloticase is a high-purity Active Pharmaceutical Ingredient (API) classified as a Uricase Enzyme / Biologic / Anti-Gout Agent. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: N/A (Biologic PEGylated Uricase).
| Parameter | Specification |
|---|---|
| CAS Number | N/A (Biologic PEGylated Uricase) |
| Molecular Formula | PEGylated Uricase (Recombinant) |
| Molecular Weight | ~540 kDa |
| Grade | I.P. / B.P. / E.P. / U.S.P. |
| Category | Uricase Enzyme / Biologic / Anti-Gout Agent |
| Appearance | White to off-white crystalline powder |
| Solubility | Slightly soluble in water; soluble in methanol |
| 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 |
| Batch No | PGL2503021 |
| Mfg Date | MAR 2025 |
| Exp Date | FEB 2030 |
| Packing | 25 kg HDPE drums / as per requirement |