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dc.creatorMaggio, Ruben Mariano-
dc.creatorCalvo, Natalia Lorena-
dc.creatorVignaduzzo, Silvana Edit-
dc.creatorKaufman, Teodoro Saul-
dc.date2016-06-02T18:36:39Z-
dc.date2016-06-02T18:36:39Z-
dc.date2014-04-
dc.date2016-06-01T13:36:17Z-
dc.date.accessioned2019-04-29T15:51:20Z-
dc.date.available2019-04-29T15:51:20Z-
dc.date.issued2014-04-
dc.identifierMaggio, Ruben Mariano; Calvo, Natalia Lorena; Vignaduzzo, Silvana Edit; Kaufman, Teodoro Saul; Pharmaceutical impurities and degradation products: Uses and applications of NMR techniques; Elsevier; Journal of Pharmaceutical and Biomedical Analysis; 101; 4-2014; 102-122-
dc.identifier0731-7085-
dc.identifierhttp://hdl.handle.net/11336/6011-
dc.identifier.urihttp://rodna.bn.gov.ar:8080/jspui/handle/bnmm/303812-
dc.descriptionCurrent standards and regulations demand the pharmaceutical industry not only to produce highly pure drug substances, but to achieve a thorough understanding of the impurities accompanying their manufactured drug substances and products. These challenges have become important goals of process chemistry and have steadily stimulated the search of impurities after accelerated or forced degradation procedures. As a result, impurity profiling is one of the most attractive, active and relevant fields of modern pharmaceutical analysis. This activity includes the identification, structural elucidation and quantitative determination of impurities and degradation products in bulk drugs and their pharmaceutical formulations. Nuclear magnetic resonance (NMR) spectroscopy has evolved into an irreplaceable approach for pharmaceutical quality assessment, currently playing a critical role in unequivocal structure identification as well as structural confirmation (qualitative detection), enabling the understanding of the underlying mechanisms of the formation of process and/or degradation impurities. NMR is able to provide qualitative information without the need of standards of the unknown compounds and multiple components can be quantified in a complex sample without previous separation. When coupled to separative techniques, the resulting hyphenated methodologies enhance the analytical power of this spectroscopy to previously unknown levels. As a result, and by enabling the implementation of rational decisions regarding the identity and level of impurities, NMR contributes to the goal of making better and safer medicines. Herein are discussed the applications of NMR spectroscopy and its hyphenated derivate techniques to the study of a wide range pharmaceutical impurities. Details on the advantages and disadvantages of the methodology and well as specific challenges with regards to the different analytical problems are also presented.-
dc.descriptionFil: Maggio, Ruben Mariano. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Rosario. Instituto de Química Rosario; Argentina-
dc.descriptionFil: Calvo, Natalia Lorena. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Rosario. Instituto de Química Rosario; Argentina-
dc.descriptionFil: Vignaduzzo, Silvana Edit. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Rosario. Instituto de Química Rosario; Argentina-
dc.descriptionFil: Kaufman, Teodoro Saul. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Rosario. Instituto de Química Rosario; Argentina-
dc.formatapplication/pdf-
dc.formatapplication/pdf-
dc.languageeng-
dc.publisherElsevier-
dc.relationinfo:eu-repo/semantics/altIdentifier/url/http://www.sciencedirect.com/science/article/pii/S0731708514002076-
dc.relationinfo:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1016/j.jpba.2014.04.016-
dc.relationinfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.jpba.2014.04.016-
dc.rightsinfo:eu-repo/semantics/restrictedAccess-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/-
dc.sourcereponame:CONICET Digital (CONICET)-
dc.sourceinstname:Consejo Nacional de Investigaciones Científicas y Técnicas-
dc.sourceinstacron:CONICET-
dc.subjectNMR spectroscopy-
dc.subjectPharmaceutical impurities-
dc.subjectStructural elucidation-
dc.subjectQualitative and quantitative analysis-
dc.subjectQuímica Analítica-
dc.subjectCiencias Químicas-
dc.subjectCIENCIAS NATURALES Y EXACTAS-
dc.titlePharmaceutical impurities and degradation products: Uses and applications of NMR techniques-
dc.typeinfo:eu-repo/semantics/article-
dc.typeinfo:eu-repo/semantics/publishedVersion-
dc.typeinfo:ar-repo/semantics/articulo-
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