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Publikation

Schneider, A.; Wessjohann, L.A.; Severi, J.A.; Wagner, V. Comparison of impurity profiles of lipiblock® vs. orlistat using HPLC and LC-MS/MS Lat. Am. J. Pharm 31, 91-96, (2012)

Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample(Xenical®, F. Hoffmann–La Roche Ltd., Switzerland) vs. generic (Lipiblock®, 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®revealed that it most likely is based on fermentation. Since the effect of the impurities is unknown, at this point fully synthetic Xenical®appears to offer a better safety margin than Lipiblock®which, however, compares quite well to other generic formulations.

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