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. |