Sulfinpyrazone API is a synthetic pyrazolidinedione derivative used primarily for its uricosuric activity. It promotes the renal elimination of uric acid and has historically been used in the management of gout and hyperuricemia. Sulfinpyrazone is chemically identified as 1,2-diphenyl-4-[2-(phenylsulfinyl)ethyl]-3,5-pyrazolidinedione, with molecular formula C₂₃H₂₀N₂O₃S and molecular weight 404.48 g/mol. Its CAS Number is 57-96-5.
Sulfinpyrazone belongs to the pyrazolidinedione class of pharmaceutical compounds. The molecule contains a phenylsulfinylethyl substituent attached to the pyrazolidinedione core. It is a crystalline solid with a melting range around 130–134°C.
The API is characterized using infrared identification and chromatographic methods. USP specifies an identity test based on IR absorption and additionally identifies the major chromatographic peak by comparison with the reference standard.
Sulfinpyrazone is a uricosuric agent that promotes renal uric-acid excretion and has been used in gout therapy. It has also demonstrated antiplatelet and antithrombotic activity.
Sulfinpyrazone has a USP drug-substance monograph. USP defines the API content at 98.5–101.5% on a dried basis. Its quality control includes identification, assay, residue on ignition, heavy metals and chromatographic purity testing.
The USP chromatographic procedure uses LC with UV detection at 235 nm. The specified system suitability requirements include a retention time of approximately 4.0–4.6 minutes, tailing factor not more than 2.0, and RSD not more than 2.0%.
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing capabilities supported by controlled processing, analytical testing and quality documentation. Sulfinpyrazone API can be evaluated against applicable USP and customer-specific requirements.
Sulfinpyrazone should be maintained in well-closed containers. USP specifies preservation in well-closed containers.
Available documentation may include:
Sulfinpyrazone has established pharmacopeial analytical requirements, including assay, chromatographic purity, residue on ignition and heavy-metal testing. Swapnroop focuses on controlled API manufacturing and analytical quality assessment aligned with applicable pharmaceutical specifications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Melting Point | 130.5–134.5°C |