Glimepiride Powder 99.36% Pharmaceutical Raw Materials CAS 93479-97-1
Pharmaceutical Raw Materials Glimepiride Powder,99.36% Glimepiride
Molecular Formula:C24H34N4O5S
Formula Weight: 490.62
CAS No.:93479-97-1
Purity:99.36%
Appearance: off white powder
Glimepiride (original trade name Amaryl) is an orally available medium-to-long-acting sulfonylurea antidiabetic drug. It is sometimes classified as either the first third-generation sulfonylurea,or as second-generation.
Glimepiride is indicated to treat type 2 diabetes mellitus; its mode of action is to increase insulin production by the pancreas. It is not used for type 1 diabetes because in type 1 diabetes the pancreas is not able to produce insulin.
Its use is contraindicated in patients with hypersensitivity to glimepiride or other sulfonylureas.
The COA:
| Product name |
Glimepiride |
| CAS No. |
93479-97-1 |
Outer Packing |
25KG/drum |
| Production date |
2016.7.12 |
Shelf life |
2019.07.11 |
| Standard adopted |
Enterprise standard |
| Items of analysis |
Specification |
Results |
|
Appearance |
White or off white powder |
off white powder |
|
Solubility |
Two soluble in dimethylformamide, soluble in dichloromethane two chloride, slightly soluble in methanol, practically insoluble in water |
Conforms |
| Identification |
IR map should be consistent with the control map |
Conforms |
| Heavy metal |
≤10 ppm |
Conforms |
| Cis-isomer(A) |
≤0.8% |
0.20% |
|
Sulfonamide(B) |
≤0.4% |
0.11% |
| Urethane(C) |
≤0.1% |
ND |
| 3-isomer(D) |
≤0.2% |
ND |
| Any other impurity |
≤0.1% |
0.08% |
| Total impurities |
≤0.5% |
0.12% |
| Residue on ignition |
≤0.2% |
0.08% |
| Loss on drying |
≤0.5% |
0.16% |
| Assay |
98.0% ～102.0 % |
99.36% |
| Conclusion |
Qualified |
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