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Pharmacopoeial Reference Standards for Elemental Impurities

  • Elemental impurities (EI) in medicinal products for human use are limited according to ICH guideline Q3D, which is in force since December 2017 in Europe and US. As a consequenceconsequence, the relevant texts of the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP) have been modified to reflect and complement ICH Q3D, providing details on the analytical methods to be used. In those chapters (Ph. Eur. 2.4.20., USP <233>), it is stated that for the quantification of elemental impurities, certified reference materials (CRM) from a national metrology institute (NMI) or reference materials that are traceable to the CRM of an NMI should be used. The Ph. Eur. has so far implemented elemental impurity standards of this type for the four most important elemental impurities i.e. those corresponding to ICH Q3D Class 1: lead, cadmium, mercury and arsenic. The poster provides details on the development of those four reference standards, which was undertaken inElemental impurities (EI) in medicinal products for human use are limited according to ICH guideline Q3D, which is in force since December 2017 in Europe and US. As a consequenceconsequence, the relevant texts of the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP) have been modified to reflect and complement ICH Q3D, providing details on the analytical methods to be used. In those chapters (Ph. Eur. 2.4.20., USP <233>), it is stated that for the quantification of elemental impurities, certified reference materials (CRM) from a national metrology institute (NMI) or reference materials that are traceable to the CRM of an NMI should be used. The Ph. Eur. has so far implemented elemental impurity standards of this type for the four most important elemental impurities i.e. those corresponding to ICH Q3D Class 1: lead, cadmium, mercury and arsenic. The poster provides details on the development of those four reference standards, which was undertaken in partnership with a major institute accredited CRM producer (JRC, European Commission), and a national metrology institute (BAM and PTB, Germany), and a Designated Institute and accredited CRM producer (BAM, Germany). The reference standards were established and characterised according to rigorous metrological principles and are supplied with extended supporting information as required for the intended use. After successful completion of the project, the four reference standards have been added to the Ph.Eur. catalogue and are in distribution. It is expected that another three elemental impurity standards will be implemented and made available to users within the next three years.zeige mehrzeige weniger

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  • 20190313 12 PREMS 040319 GBR 2707 Poster EI A0.pdf
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Metadaten
Autoren/innen:M. Weber
Koautoren/innen:A. Lodi, J. Charoud-Got, O. Rienitz, A. Röthke, Silke Richter
Dokumenttyp:Posterpräsentation
Veröffentlichungsform:Präsentation
Sprache:Englisch
Jahr der Erstveröffentlichung:2019
Organisationseinheit der BAM:1 Analytische Chemie; Referenzmaterialien
1 Analytische Chemie; Referenzmaterialien / 1.6 Anorganische Referenzmaterialien
DDC-Klassifikation:Naturwissenschaften und Mathematik / Chemie / Analytische Chemie
Freie Schlagwörter:Elemental Impurities; ICH guideline Q3D; Pharmacopoeial Reference Standards
Themenfelder/Aktivitätsfelder der BAM:Analytical Sciences
Analytical Sciences / Spurenanalytik und chemische Zusammensetzung
Veranstaltung:Joint EDQM-USP 13th International Symposium on Pharmaceutical Reference Standards
Veranstaltungsort:Strasbourg, France
Beginndatum der Veranstaltung:13.03.2019
Enddatum der Veranstaltung:14.03.2019
Verfügbarkeit des Volltexts:Volltext-PDF im Netzwerk der BAM verfügbar ("Closed Access")
Datum der Freischaltung:18.04.2019
Referierte Publikation:Nein