dc.contributor | Universidade Estadual Paulista (UNESP) | |
dc.creator | Schneider, Alex | |
dc.creator | Wessjohann, Ludger A. | |
dc.creator | Severi, Juliana A. | |
dc.creator | Wagner, Vilegas | |
dc.date | 2014-05-27T11:26:27Z | |
dc.date | 2016-10-25T18:37:03Z | |
dc.date | 2014-05-27T11:26:27Z | |
dc.date | 2016-10-25T18:37:03Z | |
dc.date | 2012-04-30 | |
dc.date.accessioned | 2017-04-06T01:58:26Z | |
dc.date.available | 2017-04-06T01:58:26Z | |
dc.identifier | Latin American Journal of Pharmacy, v. 31, n. 1, p. 91-96, 2012. | |
dc.identifier | 0326-2383 | |
dc.identifier | http://hdl.handle.net/11449/73298 | |
dc.identifier | http://acervodigital.unesp.br/handle/11449/73298 | |
dc.identifier | 2-s2.0-84860125323 | |
dc.identifier | http://www.latamjpharm.org/resumenes/31/1/LAJOP_31_1_1_14.pdf | |
dc.identifier.uri | http://repositorioslatinoamericanos.uchile.cl/handle/2250/894115 | |
dc.description | 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. | |
dc.language | eng | |
dc.relation | Latin American Journal of Pharmacy | |
dc.rights | info:eu-repo/semantics/closedAccess | |
dc.subject | Generics | |
dc.subject | HPLC-MS/MS | |
dc.subject | HPLC-UV | |
dc.subject | Orlistat | |
dc.subject | cobese | |
dc.subject | generic drug | |
dc.subject | lipiblock | |
dc.subject | orsoten | |
dc.subject | rotipuran | |
dc.subject | suprapur | |
dc.subject | tetrahydrolipstatin | |
dc.subject | unclassified drug | |
dc.subject | controlled study | |
dc.subject | drug formulation | |
dc.subject | drug impurity | |
dc.subject | drug safety | |
dc.subject | drug structure | |
dc.subject | fermentation | |
dc.subject | high performance liquid chromatography | |
dc.subject | intermethod comparison | |
dc.subject | liquid chromatography | |
dc.subject | mass spectrometry | |
dc.title | Comparison of impurity profiles of lipiblock® vs. orlistat using HPLC and LC-MS/MS | |
dc.type | Otro | |