99% Purity API Orlistat for Lose-Weight Function Pharmaceutical Grade 10 Years Experience
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99% Purity API Orlistat for Lose-Weight Function Pharmaceutical Grade for 10 Years Experience
Function
Orlistat is used with a low-calorie diet to help you lose weight and to maintain your weight after weight loss.
Orlistat is in a class of drugs called lipase inhibitors. It works in your intestines, where it blocks some of the fat you eat from being absorbed and digested. This undigested fat is then removed in your bowel movements
| Test Items | Specifications |
| Appearance | White or almost white crystalline powder |
| 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 or EP |
Certificate Of Analysis (COA)
| Items | Specification Items |
| Appearance | white or almost white crystalline powder,smell less |
| Melting Point | 42.0~46.0°C |
| Specific Rotation | -31°~-39°(CHCl3,C=1) |
| Identification | The result of HPLC is consisitent to the reference one. The result of IR is consisitent to the reference one. |
| Related Substances | ≤ 0.5% |
| Total impurity | ≤ 1.0% |
| Single impurity | ≤ 0.1% |
| n-Hexane | ≤ 290ppm |
| Isopropyl ether | ≤ 5000ppm |
| Residual on Ignition | ≤0.1% |
| Sulphate | ≤ 0.05% |
| Heavy Metal | ≤ 20ppm |
| Purity | ≤ 99.0% ~ 99.9% |
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