Tests | Specification |
Description | White Crystalline powder |
Identification HPLC IR | HPLC Retention time conforms with reference Conforms |
Specific optical rotation | -31°~41.0° |
Purity | ≥98% |
Max. individual impurity | ≤0.5% |
Total Impurities | ≤2.0% |
Water content K&F | ≤0.5% |
Melting point | 42~45°C |
Residual solvents | EtOH:≤0.5% EtOAc:≤0.5% N-Heptane:≤0.5%
|
Heavy metal | ≤20ppm |
Residue on ignition | ≤0.2% |
Assay by HPLC (orlistat) | ≥98.0% |
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