Molecular Formula

C15H21N3O3S

Molecular Weight

323.41

QualityStandard

BP/EP

Package Size

25kg/drum

Brief Introduction

Gliclazide is an oral hypoglycemic (anti-diabetic drug) and is classified as a sulfonylurea. Its classification has been ambiguous, as literature uses it as both a first-generation and second-generatio sulfonylurea. Gliclazide was shown to protect human pancreatic beta-cells from hyperglycemia-induced apoptosis. It was also shown to have an antiatherogenic effect (preventing accumulation of fat in arteries) in type 2 diabetes.

It is on the WHO Model List of Essential Medicines, the most important medications needed in a basic health system.

Appearance

White or almost white powder

White powder

Solubility

Practically insoluble in water; freely soluble in methylene chloride; sparingly soluble in acetone; slightly soluble in ethanol (96%)

Meets the requirements

Identifications

The infrared absorption spectrum is concordant with that obtained with gliclazide CRS

Meets the requirements

Heavy metals

=10ppm

<10ppm

Impurity B (HPLC)

=2ppm

0.3ppm

Related substance (HPLC)

Impurity F=0.1%

Each unspecified impurity=0.10%

Sum of impurities other than F=0.2%

N.D.

0.04%

0.1%

Loss on drying

=0.25%

0.02%

Sulfated ash

=0.1%

0.01%

Assay(onanhydrousbasis)

99.0%~101.0%

99.7%

Conclusion:Conforms with EP8