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Glibenclamide ,also known as glyburide (USAN), is an antidiabetic drug in a class of medications known as sulfonylureas, closely related to sulfonamide antibiotics.
Specification:
|
Items |
Standards |
Results |
|
Appearance |
White or almost white crystalline powder |
Conforms |
|
Melting Point |
169°C~174°C |
170.5°C~171.4°C |
|
Solubility |
Should conforms |
Conforms |
|
Identification |
IR |
Conforms |
|
Related Substance |
Impurity A: ≤0.4% Impurity B: ≤0.5% Other impurity: ≤0.2% Total impurities: ≤ 0.5% |
0.04% 0.10% 0.08% 0.21% |
|
Loss on Drying |
≤1.0% |
0.31% |
|
Heavy metals |
≤20ppm |
Conforms |
|
Sulphated ash |
≤0.1% |
0.08% |
|
Assay(on dried basis) |
99.0%~101.0% |
99.69% |
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. |
