Please use this identifier to cite or link to this item:
- Comparison of Impurity Profiles of Lipiblock (R) vs. Orlistat using HPLC and LC-MS/MS
- IDrug GmbH
- Leibniz Inst Plant Biochem
- Universidade Estadual Paulista (UNESP)
- F. Hoffmann-La Roche Ltd (Basel, Switzerland)
- Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical (R), F. Hoffmann La Roche Ltd., Switzerland) vs. generic (Lipiblock (R), EMS Sigma Pharma, a generic drug) were carried out with ethanol extracts of commercial samples. The generic formulation contained higher levels of common impurities as well as a considerable number of impurities not found in the reference product. The detected impurity profile of Lipiblock (R) revealed that it most likely is based on fermentation. Since the effect of the impurities is unknown, at this point fully synthetic Xenical (R) appears to offer a better safety margin than Lipiblock (R) which, however, compares quite well to other generic formulations.
- Latin American Journal of Pharmacy. La Plata: Colegio Farmaceuticos Provincia de Buenos Aires, v. 31, n. 1, p. 91-96, 2012.
- Colegio Farmaceuticos Provincia de Buenos Aires
- Acesso restrito
There are no files associated with this item.
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.