Glibenclamide API (CAS No. 10238-21-8), also known as Glyburide, is a synthetic oral hypoglycemic active pharmaceutical ingredient associated with type 2 diabetes mellitus, sulfonylurea antidiabetic therapy, blood glucose management, and oral antidiabetic pharmaceutical development.
Glibenclamide and Glyburide are names used for the same pharmaceutical compound.
Glibenclamide belongs to the second-generation sulfonylurea class of antidiabetic agents.
The compound primarily lowers blood glucose by stimulating insulin release from functioning pancreatic beta cells.
Sulfonylureas interact with sulfonylurea receptors associated with ATP-sensitive potassium channels in pancreatic beta-cell membranes.
Closure of ATP-sensitive potassium channels contributes to beta-cell membrane depolarization.
Membrane depolarization promotes calcium influx and stimulates insulin secretion.
The insulin-secretagogue activity of Glibenclamide forms the pharmacological basis for its use in oral antidiabetic pharmaceutical products.
Glibenclamide is associated with pharmaceutical formulations developed for management of type 2 diabetes mellitus in patients where functioning pancreatic beta cells are present.
It is used in single-active oral tablet formulations and has also been developed in fixed-dose combination pharmaceutical products with antidiabetic compounds such as Metformin Hydrochloride.
Pharmaceutical companies sourcing Glibenclamide API commonly evaluate chemical identity, HPLC assay, chromatographic purity, related substances, process-related impurities, degradation products, residual solvents, water content, particle size distribution, crystal form, polymorphic characteristics, bulk density, and batch-to-batch consistency.
Because Glibenclamide is a poorly water-soluble oral API, particle size distribution, crystal characteristics, dissolution-related properties, and formulation compatibility may be important during oral solid dosage-form development.
Impurity-profile control is also important for monitoring synthesis-related impurities, residual starting materials, intermediates, and stability-related degradation products.
Swapnroop Drugs and Pharmaceuticals supports Glibenclamide (Glyburide) API sourcing and supply requirements for qualified pharmaceutical research, antidiabetic drug development, oral tablet formulation, fixed-dose combination development, analytical requirements, and pharmaceutical manufacturing programs with product-specific documentation and secure pharmaceutical-grade packaging.
Key Features
* Glibenclamide API CAS No. 10238-21-8
* Also known as Glyburide
* Second-generation sulfonylurea API
* Oral hypoglycemic pharmaceutical ingredient
* Antidiabetic API
* Type 2 diabetes-associated pharmaceutical compound
* Insulin secretagogue
* Pancreatic beta-cell-associated mechanism
* ATP-sensitive potassium channel-associated pharmacology
* Synthetic small-molecule API
* Molecular formula C23H28ClN3O5S
* Molecular weight 494.00 g/mol
* HPLC purity profile control
* Related substance monitoring
* Process impurity control
* Degradation product monitoring
* Crystal-form characterization
* Polymorphic-form evaluation as applicable
* Particle-size requirement coordination
* Micronized grade requirements coordinated as applicable
* Residual solvent control according to applicable ICH Q3C requirements
* Elemental impurity evaluation according to applicable ICH Q3D requirements
* Pharmaceutical-grade packaging
* COA and SDS availability as applicable
* Bulk pharmaceutical supply and export coordination