Glibenclamide, also known as Glyburide, is a synthetic second-generation sulfonylurea antidiabetic API used to improve glycemic control in patients with type 2 diabetes mellitus. It stimulates pancreatic beta cells to release insulin and is generally used when dietary and lifestyle measures alone are insufficient.
Glibenclamide is a specialized oral antidiabetic pharmaceutical ingredient used in the manufacture of solid oral dosage formulations. Its production requires controlled chemical synthesis, purification and analytical testing to ensure consistent pharmaceutical quality.
CAS Number: 10238-21-8
Molecular Formula: C23H28ClN3O5S
Molecular Weight: 494.00 g/mol
Synonyms: Glyburide, Glibenclamide
Drug Class: Sulfonylurea
Therapeutic Class: Antidiabetic
Therapeutic Area: Endocrinology / Diabetes
Glibenclamide acts primarily by binding to sulfonylurea receptors (SUR1) associated with ATP-sensitive potassium channels on pancreatic beta cells. This closes potassium channels, causes membrane depolarization, promotes calcium influx and stimulates insulin secretion.
Glibenclamide is used as an oral antidiabetic medicine for the management of type 2 diabetes mellitus. It is particularly associated with improving blood glucose control through stimulation of endogenous insulin secretion.
Glibenclamide belongs to the sulfonylurea group of insulin secretagogues. Its glucose-lowering effect depends on the presence of functioning pancreatic beta cells capable of producing insulin.
Glibenclamide is a synthetic, crystalline sulfonylurea compound with the molecular formula C23H28ClN3O5S and molecular weight 494.00 g/mol. It is practically insoluble in water and is more soluble in selected organic solvents.
Glibenclamide API quality evaluation may include:
Glibenclamide should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Final storage conditions should follow validated stability data and the applicable product-specific specification.
Glibenclamide remains an established sulfonylurea compound used in pharmaceutical research, formulation development and oral antidiabetic product manufacturing. Its mechanism is based on stimulation of insulin release from pancreatic beta cells.
Glibenclamide is a second-generation sulfonylurea antidiabetic API with CAS Number 10238-21-8, molecular formula C23H28ClN3O5S, and molecular weight 494.00 g/mol. It acts primarily by stimulating insulin secretion through inhibition of ATP-sensitive potassium channels in pancreatic beta cells.
| 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) | 5.0 – 7.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 171–175°C |