Active Pharmaceutical Ingredient

Tolrestat

Also known as: Alredase; AY-27773

CAS: 82964-04-3Aldose Reductase Inhibitor / APIIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Tolrestat API — Mediocon Inc
Tolrestat — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 82964-04-3  |  MF: C₁₆H₁₄FNO₃S  |  MW: 323.35 g/mol

Tolrestat is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Tolrestat is a potent, orally active aldose reductase inhibitor investigated for the prevention and treatment of diabetic complications. It inhibits the enzyme aldose reductase, reducing sorbitol accumulation in tissues affected by diabetic neuropathy, retinopathy, and nephropathy.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Diabetic peripheral neuropathy
  • Diabetic retinopathy prevention
  • Diabetic nephropathy research
  • Aldose reductase enzyme inhibition

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameTolrestat
Also Known AsAlredase; AY-27773
CAS Number82964-04-3
Molecular FormulaC₁₆H₁₄FNO₃S
Molecular Weight323.35 g/mol
CategoryAldose Reductase Inhibitor / Active Pharmaceutical Ingredient
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in water; soluble in ethanol and DMSO
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch No.TRS/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement
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