dc.contributorIDrug GmbH
dc.contributorLeibniz Inst Plant Biochem
dc.contributorUniversidade Estadual Paulista (Unesp)
dc.date.accessioned2014-05-20T13:24:59Z
dc.date.available2014-05-20T13:24:59Z
dc.date.created2014-05-20T13:24:59Z
dc.date.issued2012-02-01
dc.identifierLatin American Journal of Pharmacy. La Plata: Colegio Farmaceuticos Provincia de Buenos Aires, v. 31, n. 1, p. 91-96, 2012.
dc.identifier0326-2383
dc.identifierhttp://hdl.handle.net/11449/7897
dc.identifierWOS:000304290800014
dc.description.abstractComparative 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.
dc.languageeng
dc.publisherColegio Farmaceuticos Provincia de Buenos Aires
dc.relationLatin American Journal of Pharmacy
dc.relation0.401
dc.relation0,152
dc.rightsAcesso restrito
dc.sourceWeb of Science
dc.subjectGenerics
dc.subjectHPLC-MS/MS
dc.subjectHPLC-UV
dc.subjectOrlistat
dc.titleComparison of Impurity Profiles of Lipiblock (R) vs. Orlistat using HPLC and LC-MS/MS
dc.typeArtículos de revistas


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