orlistat
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orlistat
orlistat is used with a low-calorie diet to help you lose weight and to maintain your weight after weight loss.mechanism:orlistat is in a class of drugs called lipase inhibitors.it works in your intestines.
Product name | Orlistat | ||
Batch No. | T12-1001001 | Mfg date | 2011.03.27 |
Test basis | TSD-QA-T12-001-022 | Retest. Date | 2014.03 |
Items | Specifications | Test results |
Description | White or almost white crystalline powder,smell-less | Conforms |
Identification | The result of HPLC is consistent to the reference one. The result of IR is consistent to the reference one. | Conforms |
Melting Point | 42~46°C | 43~44°C |
Specific rotation | -31.0°~ -37.0°(CHCl3,C=1) | -34.5° |
Rolated substances Total impurity Single impurity |
Not more than 2.0% Not more than 0.30% |
0.71% 0.21% |
Residual solvents | Methanol≤3000ppm n-Heptane≤5000ppm | 29.7ppm 63ppm |
Chloride | Not more than 200ppm | conforms |
Sulphate | Not more than 500ppm | conforms |
Residual on Ignition | Not more than 1000ppm | conforms |
Heavy metal | Not more than 20ppm | Conforms |
Assay | 98.5%---101.5% | 99.2% |
Conclusion: Complies with Manufacturer’s standard.
