Orlistat cas:96829-58-2 Orlipastat
Test Items | Specifications |
Specific Rotation | -48° ~ -51.0°(on the anhydrous, solvent-free basis) |
Identification | A.HPLC: The retention time of the major peak of the sample solution corresponds to that of the standard solution. |
B.IR: The IR spectrum of sample is consistent to the reference | |
Related Substances | |
Total impurity | Not more than 1.0% |
Related Compound A | Not more than 0.2% |
Related Compound B | Not more than 0.05% |
Related Compound C | Not more than 0.05% |
Related Compound D | Not more than 0.2% |
Related Compound E | Not more than 0.2% |
Formyl leucine | Not more than 0.2% |
Orlistat open ring epimer | Not more than 0.2% |
D-Leucine orlistat | Not more than 0.2% |
Orlistat open ring amide | Not more than 0.1% |
Individual unidentified impurity | Not more than 0.1% |
Residual Solvents | |
n-Hexane | Not more than 5000ppm |
Isopropyl ether | Not more than 5000ppm |
Residual on ignition | Not more than 0.1% |
Heavy Metal | Not more than 20ppm |
Water | Not more than 0.2% |
Assay | 98.0%~101.5% (on the anhydrous, solvent-free basis) |
Conclusion | Conform with USP35 |
Orlistat is used for the treatment of obesity.The amount of weight loss achieved with orlistat varies. In one-year clinical trials, between 35.5% and 54.8% of subjects achieved a 5% or greater decrease in body mass, although not all of this mass was necessarily fat. Between 16.4% and 24.8% achieved at least a 10% decrease in body mass.After orlistat was stopped, a significant number of subjects regained weight—up to 35% of the weight they had lost.
The incidence of type 2 diabetes in an obese population over four years is decreased with orlistat (6.2%) compared to placebo (9.0%).Long-term use of orlistat also leads to a modest reduction in blood pressure (mean reductions of 2.5 and 1.9 mmHg in systolic and diastolic blood pressure respectively).
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