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6.specification of Olistat:
Single purity not more than 0.1% version:
Items | Specification |
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 | |
Total impurity | Not more than 1.0% |
Single impurity | Not more than 0.10% |
Residual Solvents | |
n-Hexane | Not more than 290ppm |
Isopropyl ether | Not more than 5000ppm |
Sulphate | Not more than 0.05% |
Residual on Ignition | Not more than 0.1% |
Heavy Metal | Not more than 20ppm |
Assay | 99.0%~101.0% |
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(1)ISO 9001:2008 certificated company
(2)26 years in pharmaceutical industry
(3)China office of Fischer Chemicals AG (Switzerland)
Orlistat