Also known as: PPS Sodium; SP-54; Elmiron (brand); Fibrase (brand)
Pentosan Polysulfate Sodium is a semi-synthetic heparin-like polysaccharide derived from beechwood hemicellulose (xylan). Mediocon Inc manufactures this high-purity API at its GMP-certified facility in Aurangabad, Maharashtra, India. It is the only FDA-approved oral drug for interstitial cystitis (IC) and has anticoagulant and fibrinolytic properties. The compound adheres to the bladder wall, forming a protective layer that reduces inflammation.
| Parameter | Specification |
|---|---|
| CAS Number | 116001-96-8 |
| Molecular Formula | Polysaccharide Polysulfate Sodium Salt |
| Molecular Weight | ~6,000 Da (average) |
| Grade | IP / BP / EP / USP |
| Category | Urological Agent / Anticoagulant |
| 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 | PENT/24032026 |
| Mfg Date | MAR 2026 |
| Exp Date | FEB 2031 |
| Packing | 25 kg HDPE drums / as per requirement |