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Glimepiride 93479-97-1 Glimepiride 93479-97-1
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Introduction of Glimepiride:
Glimepiride is a medium- to long-acting sulfonylureaantidiabetic drug. Like all sulfonylureas, glimepiride acts as an insulin secretagogue. It lowers blood sugar by stimulating the release of insulin by pancreatic beta cells and by inducing increased activity of intracellular insulin receptors.
Not all secondary sufonylureas have the same risks of hypoglycemia. Glibenclamide (glyburide) is associated with an incidence of hypoglycemia of up to 20–30%, compared to as low as 2% to 4% with glimepiride. Glibenclamide also interferes with the normal homeostatic suppression of insulin secretion in reaction to hypoglycemia, whereas glimepiride does not. Also, glibenclamide diminishes glucagon secretion in reaction to hypoglycemia, whereas glimepiride does not.
Specification of Glimepiride:
Test Item |
Analysis Specification |
Result |
||
Description |
White crystalline powder |
White crystalline powder |
||
Identification |
IR (similar to standard) |
Conforms |
||
Related substances by HPLC |
||||
Impurity A(Cis-isomer) |
≤0.8% |
0.13% |
||
Impurity B |
≤0.4% |
0.16% |
||
Impurity C |
≤0.1% |
0.05% |
||
Impurity D |
≤0.2% |
0.11% |
||
Any other impurity |
≤0.1% |
0.08% |
||
Total impurity |
≤0.5% |
0.23% |
||
Heavy metals |
≤10ppm |
<10ppm |
||
Loss on drying |
≤0.5% |
0.19% |
||
Sulphated ash |
≤0.1% |
0.07% |
||
Assay(HPLC) |
98.0%~102.0% |
99.59% |
||
Residual solvents |
To comply the test as pre USP<467> |
Complies |
||
Conclusion |
The results Conform with USP29 Standard |
Application of Glimepiride:
Glimepiride (Glimer) is indicated to treat type 2 diabetes mellitus; its mode of action is to increase insulin production by the pancreas. It is not used for type 1 diabetes because in type 1 diabetes the pancreas is not able to produce insulin.Its use is contraindicated in patients with hypersensitivity to glimepiride or other sulfonylureas, and during pregnancy.
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