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Please use this identifier to cite or link to this item: http://acervodigital.unesp.br/handle/11449/73298
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dc.contributor.authorSchneider, Alex-
dc.contributor.authorWessjohann, Ludger A.-
dc.contributor.authorSeveri, Juliana A.-
dc.contributor.authorWagner, Vilegas-
dc.date.accessioned2014-05-27T11:26:27Z-
dc.date.accessioned2016-10-25T18:37:03Z-
dc.date.available2014-05-27T11:26:27Z-
dc.date.available2016-10-25T18:37:03Z-
dc.date.issued2012-04-30-
dc.identifierhttp://www.latamjpharm.org/resumenes/31/1/LAJOP_31_1_1_14.pdf-
dc.identifier.citationLatin American Journal of Pharmacy, v. 31, n. 1, p. 91-96, 2012.-
dc.identifier.issn0326-2383-
dc.identifier.urihttp://hdl.handle.net/11449/73298-
dc.identifier.urihttp://acervodigital.unesp.br/handle/11449/73298-
dc.description.abstractComparative 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.en
dc.format.extent91-96-
dc.language.isoeng-
dc.sourceScopus-
dc.subjectGenerics-
dc.subjectHPLC-MS/MS-
dc.subjectHPLC-UV-
dc.subjectOrlistat-
dc.subjectcobese-
dc.subjectgeneric drug-
dc.subjectlipiblock-
dc.subjectorsoten-
dc.subjectrotipuran-
dc.subjectsuprapur-
dc.subjecttetrahydrolipstatin-
dc.subjectunclassified drug-
dc.subjectcontrolled study-
dc.subjectdrug formulation-
dc.subjectdrug impurity-
dc.subjectdrug safety-
dc.subjectdrug structure-
dc.subjectfermentation-
dc.subjecthigh performance liquid chromatography-
dc.subjectintermethod comparison-
dc.subjectliquid chromatography-
dc.subjectmass spectrometry-
dc.titleComparison of impurity profiles of lipiblock® vs. orlistat using HPLC and LC-MS/MSen
dc.typeoutro-
dc.contributor.institutionIDrug GmbH-
dc.contributor.institutionLeibniz Institute of Plant Biochemistry-
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)-
dc.description.affiliationIDrug GmbH, Berlin-
dc.description.affiliationDepartment of Bioorganic Chemistry Leibniz Institute of Plant Biochemistry, Halle (Saale)-
dc.description.affiliationSchool of Pharmaceutical Sciences UNESP São Paulo State University, Araraquara-
dc.description.affiliationInstitute of Chemistry UNESP São Paulo State University, Araraquara-
dc.description.affiliationUnespSchool of Pharmaceutical Sciences UNESP São Paulo State University, Araraquara-
dc.description.affiliationUnespInstitute of Chemistry UNESP São Paulo State University, Araraquara-
dc.rights.accessRightsAcesso restrito-
dc.relation.ispartofLatin American Journal of Pharmacy-
dc.identifier.scopus2-s2.0-84860125323-
Appears in Collections:Artigos, TCCs, Teses e Dissertações da Unesp

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