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Gliclazide
Chemical Name | ：Gliclazide |
Category | ：Hypoglycemic |
Hypoglycemic | ：EP/BP |
HS Code | ：2935.0090.90 |
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Structure Formula | ： |
CAS Number | ：21187-98-4 |
Molecular | ：C15H21N3O3S |
Usage | ：The hypoglycemic effect of adult patients with type 2 diabetes, can reduce platelet adhesion force, reduced plasma viscosity, reduced the ADP induced platelet aggregation, improving microcirculation. In addition, the experiment proved that, this product has lower cholesterol accumulation, reduced aortic three phosphoric acid glyceride and fatty acid concentration in plasma. Therefore, the combination of the two, which can be used for treatment of diabetic metabolic disturbance, but also can prevent vascular disease, retinopathy and renal function improvement. For adult onset diabetes, diabetes accompanied by obesity or vascular lesion. |
Items | Standard |
|---|---|
Characteristics | A white or almost white powder |
Solubility | Is almost insoluble in water, soluble in dichloromethane, slightly soluble in acetone, slightly soluble in ethanol (96%) |
Identification | The infrared absorption spectrum is concordant with the reference spectrum |
Heavy metals | ≤10ppm |
Impurity B | ≤2ppm |
Related substances | Impurity F≤0.1% Other individual ≤0.10% Sum of impurities other than F ≤0.2% |
Loss on drying | ≤0.25% |
Sulfated ash | ≤0.1% |
Assay | 99.0~101.0%,on dried basis |
Conclusion | The test results conform with BP2009 |
1， Argentinian National Institute of Drugs
Instituto Nacional de Medicamentos (INAME)
2， Australian Therapeutic Goods Administration (TGA)
3， Belgian Federal Agency for Medicines and Health Products
Agence Fédérale des Médicaments et des Produits de Santé(AFMPS)
Federaal Agentschap voor Geneesmiddelen enGezondheidsproducten (FAGG)
4， Canadian Health Products and Food Branch Inspectorate(HPFBI)
5， Taiwan Food and Drug Administration (TFDA)
7， Czech State Institute for Drug Control
Státní Ústav pro Kontrolu Léčiv (SÚKL)
8， Czech Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM)
9， Danish Health and Medicines Authority (DHMA)
10， Finnish Medicines Agency (FIMEA)
11， French National Agency for Medicines and Health Products Safety
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
12， French Agency for Food, Environmental & Occupational Health Safety
Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)
13， German Federal Ministry of Health *
Bundesministerium für Gesundheit (BMG)
14， Icelandic Medicines Agency (IMA)
20， Indonesian National Agency for Drug and Food Control (NADFC)
21， Health Products Regulatory Authority (HPRA)
22， Italian Medicines Agency
Agenzia Italiana del Farmaco (AIFA)
23， Japanese Pharmaceuticals and Medical Devices Agency(PMDA)
24， Korea (Republic of) Ministry of Food and Drug Safety (MFDS)
25， Malaysian National Pharmaceutical Control Bureau (NPCB)
26， Dutch Health Care Inspectorate*
Inspectie voor de Gezondheidszorg (IGZ)
27， New Zealand's Medicines and Medical Devices Safety Authority (Medsafe)
28， Norwegian Medicines Agency (NOMA)
29， Polish Main Pharmaceutical Inspectorate (MPI)
30， Romanian National Agency for Medicines and MedicalDevices (NAMMD)
31， South African Medicines Control Council (MCC)
32， Spanish Agency of Medicines and Medical Devices *
Agencia Española de Medicamentos y Productos Sanitarios(AEMPS)
33， Swedish Medical Products Agency (MPA)
34， United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA)
35， United Kingdom's Veterinary Medicine Directorate (VMD)
36， U.S. Food and Drug Administration (US FDA)
37， European Directorate for the Quality of Medicines & HealthCare （EDQM）
38， European Medicines Agency（EMA）
39， World Health Organization（WHO）