European Pharmacopoeia (EP) Reference Standard

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pharmaceutical primary standard




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163-169 °C (lit.)

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General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.For further information and support please go to the website of the issuing Pharmacopoeia.


Used in the treatment of non-insulin dependent diabetes mellitus (NIDDM).

Biochem/physiol Actions

Oxidative modification of low-density lipoprotein (LDL) plays an important role in vascular dysfunction associated with diabetes mellitus. Gliclazide is a second-generation sulfonylurea with free-radical-scavenging activity. Incubation of human aortic smooth muscle cell (HASMC) with native human LDL (100 μg/mL) in the presence of increasing concentrations of gliclazide (1 to 10 μg/mL) resulted in a dose-dependent decrease in HASMC-mediated LDL oxidation. Exposure of HASMCs to gliclazide (1 to 10 μg/mL) and native LDL (100 μg/mL) also led to a dose-dependent decrease in oxidized LDL-induced human monocyte adhesion to HASMCs. In addition, incubation of HASMCs with gliclazide dramatically reduced the ability of oxidized LDL to stimulate the proliferation of these cells. Finally, treatment of HASMCs with gliclazide resulted in a marked decrease in oxidatively modified LDL-induced monocyte chemoattractant protein (MCP)-1 and human heat shock protein 70 (HSP 70) expression, both at the gene and protein levels. These results show that gliclazide, at concentrations in the therapeutic range (5 to 10 μg/mL), is effective in vitro in reducing vascular smooth muscle cell (VSMC) dysfunction induced by oxidatively modified LDL. Administration of gliclazide to type 2 diabetic patients could form part of the strategy for the prevention and management of diabetic cardiovascular diseases


Unit quantity: 20 mg. Subject to change. The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference subtance catalogue.


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NONH for all modes of transport

WGK Germany


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Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis
Certificate of Origin
O Ziegler et al.
Journal of diabetes and its complications, 8(4), 235-239 (1994-10-01)
Non-insulin-dependent diabetes mellitus (NIDDM) is associated with an increased risk of macro- and microvascular degenerative complications. Gliclazide is a second generation sulfonylurea that is widely used in the treatment of type II diabetes mellitus. Its hypoglycemic activity is well documented....
A Harrower
Metabolism: clinical and experimental, 49(10 Suppl 2), 7-11 (2000-11-15)
Although sulfonylureas have been used for more than 40 years, it is only recently that their molecular mechanisms of action have been elucidated. Gliclazide modified release, whose introduction comes soon after the sequencing and cloning of the sulfonylurea receptor, is...
Guntram Schernthaner
Metabolism: clinical and experimental, 52(8 Suppl 1), 29-34 (2003-08-27)
Gliclazide modified release (MR) is a new formulation of the drug gliclazide and is given once daily. The specifically designed hydrophilic matrix of gliclazide MR leads to a progressive drug release that parallels the 24-hour glycemic profile in type 2...
Gábor Winkler
Orvosi hetilap, 155(14), 541-548 (2014-04-01)
In addition to the common blood glucose lowering effect, sulfonylurea compounds are different in many aspects from each other. Based on earlier findings the second generation gliclazide has special advantages within this group. Although the number of experimental and clinical...
Geneviève Renier et al.
Metabolism: clinical and experimental, 52(8 Suppl 1), 13-18 (2003-08-27)
Atherosclerotic cardiovascular disease is the leading cause of premature death in patients with diabetes. Atherosclerosis is a chronic immune-mediated disease, the initiation, progression, and destabilization of which is driven and regulated by inflammatory cells. One critical event in the initiation...

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