- E-mail : info@unihealthcarepharm.org
Orlistat is a drug designed to treat obesity. Its primary function is preventing the absorption of fats from the human diet by acting as a lipase inhibitor, thereby reducing caloric intake. It is intended for use in conjunction with a healthcare provider-supervised reduced-calorie diet.
Specification:
|
Item |
Requirements |
Test Results |
|
Appearance |
while to off-while powder |
White powder |
|
Identification |
HPLC retention time |
Conforms |
|
Melting Point |
42 ºC -45°C |
42°C-44°C |
|
Specific optical rotation |
-31.0°~-41.0° |
-36.0° |
|
Purity by HPLC |
no less than 98.0% |
98.5% |
|
Total impurity |
no more than 2.0% |
1.6% |
|
Max Individual impurity |
no more than 0.5% |
0.3% |
|
Water content%(K&F) |
no more than 0.5% |
0.1% |
|
Residual solvents |
EtOH no more than 0.5% |
N.D |
|
EtAC no more than 0.5% |
N.D |
|
|
n-Heptane no more than 0.5% |
less than 0.1% |
|
|
Residue on ignition |
less than 0.2% |
0.10% |
|
Heavy metals as Pb |
no more than 20ppm |
less than20ppm |
|
Assay (HPLC) |
no less than 98.0% |
98.60% |
|
Conclusion |
Meets the Requirements |
|
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. |
