Product Name | Orlistat |
Package | 25KG Bag |
Specific rotation | -48.0°~ -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 standard. |
Appearance | White to off-white fine powder or fine powder with lumps |
Related Substances | |
Total impurity | ≤1.0% |
Related Compound A  | ≤0.2% |
Related Compound B | ≤0.05% |
Related Compound C | ≤0.05% |
Related Compound D | ≤0.2% |
Related Compound E | ≤0.2% |
Formylleucine | ≤0.2% |
Orlistat open ring epimer  | ≤0.2% |
D-Leucine orlistat | ≤0.2% |
Orlistat open ring amide | ≤0.1% |
Individual unidentified impurity | ≤0.1% |
Residual Solvents | |
N-heptane | ≤5000ppm |
Isopropyl ether | ≤5000ppm |
Methanol | ≤3000ppm |
Tetrahydrofuran | ≤720ppm |
Residual on ignition | ≤0.1% |
Heavy metals | ≤20ppm |
Assay | 98.0%~101.5%(on the anhydrous,solvent-free basis) |
Water | ≤0.2% |
Product Name | Orlistat |
Package | 25KG Bag |
Specific rotation | -48.0°~ -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 standard. |
Appearance | White to off-white fine powder or fine powder with lumps |
Related Substances | |
Total impurity | ≤1.0% |
Related Compound A  | ≤0.2% |
Related Compound B | ≤0.05% |
Related Compound C | ≤0.05% |
Related Compound D | ≤0.2% |
Related Compound E | ≤0.2% |
Formylleucine | ≤0.2% |
Orlistat open ring epimer  | ≤0.2% |
D-Leucine orlistat | ≤0.2% |
Orlistat open ring amide | ≤0.1% |
Individual unidentified impurity | ≤0.1% |
Residual Solvents | |
N-heptane | ≤5000ppm |
Isopropyl ether | ≤5000ppm |
Methanol | ≤3000ppm |
Tetrahydrofuran | ≤720ppm |
Residual on ignition | ≤0.1% |
Heavy metals | ≤20ppm |
Assay | 98.0%~101.5%(on the anhydrous,solvent-free basis) |
Water | ≤0.2% |