Swapnroop Drugs & Pharmaceuticals is a pharmaceutical Tolrestat API manufacturer and supplier in India, providing pharmaceutical-grade active pharmaceutical ingredients for qualified pharmaceutical manufacturers, formulation companies, research organizations, and bulk procurement requirements.
Tolrestat is a synthetic aldose reductase inhibitor (ARI) developed for investigation and treatment of diabetic complications. It is chemically classified as a carboxylic acid derivative and is associated with inhibition of the polyol pathway enzyme aldose reductase (AKR1B1). Tolrestat has been investigated particularly for its potential application in diabetic peripheral neuropathy.
Tolrestat is identified by CAS 82980-32-9, with molecular formula C₁₆H₁₄N₂O₃S and molecular weight 298.36 g/mol.
Tolrestat is chemically known as 3,4-dihydro-4-oxo-3-(4-nitrophenyl)-1-phthalazineacetic acid. It is a small-molecule aldose reductase inhibitor designed to reduce the conversion of glucose to sorbitol through inhibition of aldose reductase.
The API has been studied extensively in relation to diabetic neuropathy and other complications associated with increased intracellular sorbitol accumulation.
Tolrestat has been investigated as an aldose reductase inhibitor for diabetic complications, particularly diabetic peripheral neuropathy.
Aldose reductase catalyzes the first step of the polyol pathway, converting glucose to sorbitol. Inhibition of this enzyme was investigated as a strategy to reduce sorbitol accumulation in tissues affected by chronic hyperglycemia.
Tolrestat has historically been evaluated in clinical studies for diabetic neuropathy but is not a currently marketed systemic pharmaceutical in many major markets. Accordingly, its supply should be considered in the context of applicable regulatory and customer requirements.
Swapnroop supports qualified pharmaceutical and research customers requiring Tolrestat API for development, analytical, formulation, and bulk procurement applications.
Supply specifications can be established according to the intended application, applicable regulatory market, and customer quality requirements.
Tolrestat API should be stored in a suitable pharmaceutical-grade, tightly closed container under controlled conditions. The material should be protected from contamination, excessive moisture, and unsuitable environmental exposure.
Final storage requirements should follow the applicable product specification and stability data.
Subject to the applicable supply arrangement, documentation may include:
Swapnroop Drugs & Pharmaceuticals provides Tolrestat API for qualified pharmaceutical, research, formulation, and bulk procurement requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Melting Point | 164–165°C |