Product Brief Introduction
Product name: Orlistat
CAS：96829-58-2
MF: C29H53NO5
MW: 495.735
Product Specification
|
Item |
Specification |
|
Appearance |
White or off white crystalline powder |
|
Identification |
HPLC: The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
|
IR spectrum should comply with that of its RS |
|
|
Solubility |
Very soluble in methanol and ethanol freely soluble in chloroform, practically insoluble in water |
|
Moisture |
≤ 0.5% |
|
Residue on Ignition |
≤ 0.1% |
|
Melting Point |
42.0℃~46.0℃ |
|
Specific Rotation |
-48.0°~-51.0° |
|
Related Substances |
Any other single impurity ≤ 1.0% |
|
Total impurities ≤ 2.0% |
|
|
Residual Solvents |
Methanol≤ 3000ppm |
|
Ethanol≤ 5000ppm |
|
|
Acetonitrile≤ 410ppm |
|
|
Heptane≤ 5000ppm |
|
|
Heavy Metals |
≤ 20ppm |
|
Lead |
≤ 5ppm |
|
Total Plate Count |
≤ 900cfu/g |
|
Yeasts&Molds |
≤ 90cfu/g |
|
E.Coli |
Negative |
|
D10 |
Measured Value |
|
D50 |
Measured Value |
|
D90 |
Measured Value |
|
Assay (on dried basis) |
≥ 98.0% |
