Active Pharmaceutical Ingredient

Tolbutamide

Also known as: Orinase; Rastinon

CAS: 64-77-7Sulfonylurea / Antidiabetic APIIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Tolbutamide API — Mediocon Inc
Tolbutamide — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 64-77-7  |  MF: C₁₂H₁₈N₂O₃S  |  MW: 270.35 g/mol

Tolbutamide 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.

Tolbutamide is a first-generation sulfonylurea antidiabetic agent that stimulates insulin secretion from pancreatic beta cells by blocking ATP-sensitive potassium channels. It is used in the management of type 2 diabetes mellitus.

Key Features

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

Applications

  • Type 2 diabetes mellitus management
  • Insulin secretion stimulation
  • Blood glucose regulation
  • Oral antidiabetic therapy

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 NameTolbutamide
Also Known AsOrinase; Rastinon
CAS Number64-77-7
Molecular FormulaC₁₂H₁₈N₂O₃S
Molecular Weight270.35 g/mol
CategorySulfonylurea / Antidiabetic Agent / Active Pharmaceutical Ingredient
AppearanceWhite crystalline powder
SolubilityPractically insoluble in water; soluble in acetone and alcohol
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.TOL/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement
💬
Mediocon AI
Hello 👋 How can I help you today?