- E-mail : info@ggolden.co.uk
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. |
