Product name | Gliclazide |
CAS No. | 21187-98-4 |
Molecular Formula | C15H21N3O3S |
Molecular Weight | 323.4105 |
Quality Standard | 99% up by HPLC, Medical Grade |
Appearance | White powder |
Item | Specification | Test Result |
Characteristics | White or almost white powder | White powder |
Solubility | Practically insoluble in water: freely soluble in methylene chloride; Sparingly soluble in acetone(96%); slightly soluble in alcohol (96%) | Conforms |
M.P | 162-166°C | 164.0-164.5° C |
Identification | Conform to the spectrum of the CRS Gliclazide | Conforms |
Heavy metals | ≤10ppm | <10ppm |
Impurity B | ≤2ppm | 0.3ppm |
Related substances | Impurity F ≤0.10% | <0.10% |
Other single impurity ≤0.10% | <0.10% |
Total of other impurities ≤0.2% | <0.13% |
Loss on drying | ≤0.25% | 0.10% |
Sulphated ash | ≤0.1% | 0.01% |
Residual solvents | Ethyl acetate ≤0.5% | Below LOQ |
Toluene ≤0.089% | Below LOQ |
Assay (on dried basis) | 99.0%-101.0% | 99.5% |
Conclusion | The Results Conforms With Enterprise Standards
|
Function of Gliclazide
Gliclazide is a second-generation sulfonylurea hypoglycemic drug, which is a secretion promoter. Its hypoglycemic mechanism is to selectively act on the β cells of the pancreatic islets to promote the secretion of insulin and increase the secretion of insulin after eating, so that the liver Glycogen production and output are inhibited, which is helpful for the prevention and treatment of diabetic microvascular disease. Gliclazide has a long and stable action time, and is generally used in elderly patients. Gliclazide is generally absorbed quickly after oral administration, reaching a peak in 3-4 hours, and 80% is excreted from the kidneys. If the kidney function is not good, attention should be paid. Less common side effects are gastrointestinal reactions, such as nausea and vomiting, and the incidence of hypoglycemia is less than that of other sulfonylureas. Gliclazide can be used alone or simultaneously with other hypoglycemic drugs. Its hypoglycemic level is practical and reliable, and it can be combined with biguanides, insulin sensitizers, DPP-4 inhibitors and insulin, and different combinations can be made according to different conditions of patients.
