Description

Gliclazide is a second-generation sulfonylurea compound, a key active pharmaceutical ingredient (API) used in the management of type 2 diabetes mellitus. Its primary value lies in its ability to stimulate insulin secretion from pancreatic β-cells, thereby helping to regulate blood glucose levels effectively. This product is essential for pharmaceutical manufacturers engaged in the production of oral anti-diabetic medications. We supply high-purity Gliclazide CAS NO 21187-98-4 to meet the stringent demands of global pharmaceutical development and production.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral anti-diabetic tablets and formulations.
• Drug Development: Serves as a critical reference standard and raw material in R&D for new diabetes therapies.
• Generic Medicine Production: Used by manufacturers to produce cost-effective generic versions of gliclazide-based medications.
• Controlled-Release Formulations: Incorporated into modified-release tablets designed for sustained, 24-hour glycemic control.
• Combination Therapies: Potential component in fixed-dose combination drugs for enhanced diabetes management.
• Clinical Research: Utilized in clinical trials and studies investigating diabetes treatment protocols.

Basic Information

Product Name	Gliclazide
CAS No.	21187-98-4
Molecular Formula	C15H21N3O3S
Molecular Weight	323.41 g/mol
Synonyms	1-(3-Azabicyclo[3.3.0]oct-3-yl)-3-(p-tolylsulfonyl)urea; N-(Hexahydrocyclopenta[c]pyrrol-2(1H)-ylcarbamoyl)-4-methylbenzenesulfonamide; Diamicron (brand name); Glyzide; Glidiabet; Glizid; Unidia; Glyclazide
EINECS	244-260-1

Quality Control

Our Gliclazide is manufactured under strict quality management systems to ensure it meets the high standards required for pharmaceutical use. Quality is verified through comprehensive analytical testing, including HPLC for assay and impurity profiling. We can supply material compliant with various pharmacopoeial standards, including EP and USP. A Certificate of Analysis (COA) detailing purity, identity, and specific tests is provided with each batch to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The container should be kept tightly sealed when not in use.

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 anhydrous 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.