Description

Glibenclamide is a potent second-generation sulfonylurea pharmaceutical compound, widely recognized for its role in the management of type 2 diabetes mellitus. Its primary value lies in its ability to stimulate insulin secretion from pancreatic β-cells, thereby effectively lowering blood glucose levels. This active pharmaceutical ingredient (API) is essential for manufacturers in the global pharmaceutical industry, particularly those producing oral anti-diabetic medications. Glibenclamide CAS NO 10238-21-8 is a critical component in ensuring the efficacy and reliability of finished drug products.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral anti-diabetic tablets and formulations for the treatment of non-insulin-dependent diabetes mellitus (NIDDM).
• Fixed-Dose Combination Drugs: Used in combination with other anti-diabetic agents like metformin to create synergistic therapeutic effects.
• Research & Development: Serves as a key reference standard and biochemical tool in metabolic disorder research, pharmacology studies, and drug discovery.
• Generic Drug Manufacturing: A fundamental API for the production of cost-effective generic versions of branded sulfonylurea medications.
• Veterinary Medicine: Investigational and applied use in the management of diabetes in companion animals.
• Clinical Trial Materials: Supplied as a high-purity compound for use in clinical studies and bioequivalence testing.

Basic Information

Item	Detail
Product Name	Glibenclamide
CAS No.	10238-21-8
Molecular Formula	C23H28ClN3O5S
Molecular Weight	494.00 g/mol
Synonyms	Glyburide; N-[4-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulfonyl]-N′-cyclohexylurea; 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea; Daonil; Euglucon; Gliben; Micronase; Glynase; Semi-Daonil
EINECS	233-570-6

Quality Control

Our Glibenclamide is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP, EP, and JP. Every batch undergoes rigorous analytical testing including identification, assay, and impurity profiling to ensure identity, strength, quality, and purity. A comprehensive Certificate of Analysis (COA) documenting all test results is provided with each shipment to guarantee traceability and regulatory compliance for our pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on dried basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Loss on Drying	≤ 0.5%
Sulfated Ash	≤ 0.1%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.