Also known as: Renagel / Renvela Active
Sevelamer Hydrochloride is a non-absorbable, calcium-free, metal-free phosphate-binding polymer used in patients with chronic kidney disease (CKD) on dialysis. It binds dietary phosphate in the gastrointestinal tract, reducing serum phosphorus levels and preventing hyperphosphatemia complications such as cardiovascular calcification. As a cross-linked polymer, it is not systemically absorbed. Mediocon Inc supplies GMP-certified Sevelamer Hydrochloride API meeting pharmacopoeial standards.
| Parameter | Specification |
|---|---|
| CAS Number | 112665-43-7 |
| Molecular Formula | Crosslinked poly(allylamine·HCl) |
| Molecular Weight | Polymer (avg ~9,000 Da) |
| Grade | IP / BP / EP / USP |
| Category | Phosphate Binder / Renal |
| 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 2025 |
| Exp Date | FEB 2031 |
| Packing | 25 kg HDPE drums / as per requirement |