Orlistat (CAS 96829-58-2, C29H53NO5, MW 495.7) is a semi-synthetic lipase inhibitor supplied as a high-purity pharmaceutical active ingredient (API) in USP and EP grades. It is the hydrogenated derivative of the natural product lipstatin, produced by controlled fermentation followed by catalytic hydrogenation, and is characterized by a fully defined impurity profile. PolyBlueChem supplies Orlistat as a white to quasi-white crystalline powder for pharmaceutical formulation, reference standard use and process development.
Specifications
| Parameter | Specification |
|---|---|
| Appearance | White or quasi-white crystalline powder |
| Optical rotation | -48° to -51° (20°C, 30 mg/mL in dehydrated alcohol) |
| Assay (anhydrous, solvent-free basis) | 98.0% – 101.5% |
| Residue on ignition | NMT 0.1% |
| Residual water | NMT 0.2% |
Impurity Profile
| Impurity | Limit |
|---|---|
| Orlistat Related Compound A | NMT 0.2% |
| Orlistat Related Compound B | NMT 0.05% |
| Orlistat Related Compound C | NMT 0.05% |
| Orlistat Related Compound D | NMT 0.2% |
| N-Formyl-L-leucine | NMT 0.2% |
| Orlistat open ring epimer | NMT 0.2% |
| D-Leucine orlistat | NMT 0.2% |
| Orlistat open ring amide | NMT 0.1% |
| Individual unidentified impurity | NMT 0.1% |
| Total impurities | NMT 1.0% |
Applications
- Active pharmaceutical ingredient for oral solid dosage forms based on gastrointestinal lipase inhibition.
- Reference standard and impurity profiling in pharmaceutical quality-control laboratories.
- Formulation research on oral delivery of poorly water-soluble active ingredients.
Storage and Packaging
Store in tight, light-resistant containers at controlled room temperature (below 25°C), protected from moisture. Typically supplied in double-lined fiber drums of 1 kg, 5 kg or 25 kg, or as agreed. Recommended retest period and storage conditions are stated on the Certificate of Analysis (COA).
Chemical Structure
CCCCCCCCCCC[C@@H](C[C@H]1[C@@H](C(=O)O1)CCCCCC)OC(=O)[C@H](CC(C)C)NC=O
FAQ
Which grades of Orlistat do you supply? Orlistat is supplied in USP and EP grades as a white to quasi-white crystalline powder, with an assay of 98.0% to 101.5% on the anhydrous, solvent-free basis.
What documentation is available? A Certificate of Analysis (COA) covering assay, optical rotation, water, residue on ignition and the related-substance profile is provided with each lot. Additional documentation can be supplied on request.
How is Orlistat packaged and stored? Standard packaging is double-lined fiber drums; store below 25°C, protected from light and moisture.
