Epalrestat is a synthetic aldose reductase inhibitor (ARI) used primarily in the management of diabetic peripheral neuropathy. It inhibits aldose reductase, an enzyme involved in the polyol pathway of glucose metabolism. By reducing the conversion of glucose to sorbitol, Epalrestat helps reduce intracellular accumulation of sorbitol associated with diabetic nerve complications.
Epalrestat is a noncompetitive inhibitor of aldose reductase and is particularly associated with pharmaceutical treatment of diabetic neuropathy.
Epalrestat is an orally active small-molecule pharmaceutical ingredient belonging to the aldose reductase inhibitor class. It is chemically characterized as a carboxylic-acid-containing compound and is used in certain markets for diabetic neuropathy.
Epalrestat has the molecular formula C₁₅H₁₃NO₃S₂ and molecular weight approximately 319.40 g/mol.
Swapnroop Drugs and Pharmaceuticals provides Epalrestat API for qualified pharmaceutical manufacturing, formulation development, research and pharmaceutical sourcing requirements.
Epalrestat is a specialized diabetic neuropathy API relevant to pharmaceutical formulations targeting complications associated with diabetes.
Epalrestat inhibits aldose reductase, the first enzyme of the polyol pathway.
Under hyperglycemic conditions, increased glucose metabolism through the polyol pathway can lead to accumulation of sorbitol and fructose in tissues. Inhibition of aldose reductase by Epalrestat reduces this pathway and may help limit polyol accumulation in peripheral nerves.
Epalrestat is associated with:
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |