Item | Specification |
Identification | HPLC, IR |
Specific optical rotation | -48.0°~-51.0° |
Water content | ≤0.2% |
Related substances I | Orlistat related compound A ≤0.2% |
Related substances II | Orlistat related compound B ≤0.05% |
Related substances III | Formylleucine ≤0.2% |
Orlistat related compound C ≤0.05% | |
Orlistat open ring epimer ≤0.2% | |
D-Leucine orlistat ≤0.2% | |
Individual unidentified impurity ≤0.1% | |
Related substances IV | Orlistat related compound D ≤0.2% |
Orlistat open ring amide ≤0.1% | |
Related substances V | Orlistat related compound E ≤0.2% |
Total impurities (I to V) | ≤1.0% |
Residual solvents | Methanol ≤0.3% |
EtOAc ≤0.5% | |
n-Heptane ≤0.5% | |
Residue on ignition | ≤0.1% |
Heavy metals as Pb | ≤20ppm |
Assay by HPLC | 98.0%~101.5% (on anhydrous, solvent-free basis) |
Synonyms: (−)- Tetrahydrolipstatin, Ro-18-0647,
N- Formyl- L-leucine (1S)- 1- [[(2S,3S)- 3- hexyl- 4- oxo- 2- oxetanyl]methyl]dodecyl ester
CAS No.: 96829-58-2
Quality: USP42
Molecular Formula: C29H53NO5
Formula Weight: 495.73