奧利司他
Product | 奧利司他 |
batch No. | 20200221 |
CAS No. | 96829-58-2 |
Tests | Specifications |
Description | Appearance: white or almost white crystalline powder |
| Solubility: very soluble in methanol and ethanol, freely soluble in chloroform, practically insoluble in water. |
Melting point | 42 ~ 46°C |
Identification | HPLC: the retention time of principal peak should comply with its RS. |
| IR spectrum should, comply with that of its RS. |
Specific rotation | -48° ~-51°。 |
Related substance | Any other Single impurity NMT 1.0% |
| Total impurities NMT 2.0% |
Residual solvents | Methanol NMT 3000ppm |
| Ethanol NMT 5000ppm |
| Acetonitrile NMT 410ppm |
| Heptane NMT 5000ppm |
Water | NMT 0.5% |
Residue on ignition | NMT 0.1% |
Heavy metals | NMT 20ppm |
Assay | NLT 98.0% (on the anhydrous basis) |
Conclusion 結論 : Conforms to the requirements of in house standard. |