Description
Gliclazide is used for control of hyperglycemia in gliclazide-responsive diabetes mellitus of stable, mild, non-ketosis prone, type 2 diabetes. It is used when diabetes cannot be controlled by proper dietary management and exercise or when insulin therapy is not appropriate.
Specification:
| Items | Acceptable criteria | Results |
| Characteristics | A white or almost white powder | A 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% | 0.1% |
| 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 test results conform with IP/BP | |
Packaging details:
| Packaging details: | 25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
| Storage: | Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
| Shelf Life: | 5 years if sealed and store away from direct sun light. |
Additional Information
The most widely recognized markets for this item incorporate the accompanying nations. If you don’t mind ask with us if your nation or district isn’t recorded:
ASIA: Afghanistan, Israel, Jordan, Pakistan, Russia, Saudi Arabia, Singapore, Syria, Philippines, Turkey, Turkmenistan, Uzbekistan, Yemen, Vietnam, Indonesia, Malaysia, Iran, Tajikistan, and so forth.
AFRICA: South Africa, Uganda, Nigeria, Ghana, Kenya, Mauritius, Botswana, Egypt, Ethiopia, Libya, Sudan, Congo, Gambia, Ivory Coast , and so forth.
NORTH & SOUTH AMERICA: USA, Canada, Panama, Trinidad and Tobago, Costa Rica, Puerto Rico, Dominican Republic, Argentina, Guatemala, Guyana, Peru, Bolivia, Venezuela , Brazil, Bahamas, Ecuador, and so forth .
EUROPE: Austria , Azerbaijan, Belarus, Belgium, Cyprus, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Ireland, Iceland, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom (UK) , Latvia, and so forth.
OCEANIA: Australia, New Zealand, Fiji, and so forth.
