Related impurities in peptide medicines.

D'Hondt, Matthias; Bracke, Nathalie; Taevernier, Lien; Gevaert, Bert; Verbeke, Frederick; Wynendaele, Evelien; De Spiegeleer, Bart

D'Hondt, Matthias; Bracke, Nathalie; Taevernier, Lien; Gevaert, Bert; Verbeke, Frederick; Wynendaele, Evelien; De Spiegeleer, Bart.

Afiliação

D'Hondt M; Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.
Bracke N; Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.
Taevernier L; Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.
Gevaert B; Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.
Verbeke F; Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.
Wynendaele E; Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.
De Spiegeleer B; Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium. Electronic address: Bart.DeSpiegeleer@UGent.be.

J Pharm Biomed Anal ; 101: 2-30, 2014 Dec.

Article em En | MEDLINE | ID: mdl-25044089

Assuntos

Peptídeos/química; Contaminação de Medicamentos; Descoberta de Drogas/métodos; Humanos

Palavras-chave

Peptide degradation; Peptide impurity profiling; Peptide-excipient interaction; Quality by design (QbD); Solid-phase peptide synthesis (SPPS)

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Texto completo: 1 Coleções: 01-internacional Temas: Geral Base de dados: MEDLINE Assunto principal: Peptídeos Limite: Humans Idioma: En Revista: J Pharm Biomed Anal Ano de publicação: 2014 Tipo de documento: Article País de afiliação: Bélgica

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