{"id":3976,"date":"2019-11-26T13:17:05","date_gmt":"2019-11-26T12:17:05","guid":{"rendered":"https:\/\/www.kromidas.de\/validierung\/nuetzliches\/kompakte-informationen\/ueberpruefung-der-robustheit\/"},"modified":"2021-02-12T11:41:22","modified_gmt":"2021-02-12T10:41:22","slug":"ueberpruefung-der-robustheit","status":"publish","type":"page","link":"https:\/\/www.kromidas.de\/en\/validation\/useful\/compact-information\/ueberpruefung-der-robustheit\/","title":{"rendered":"\u00dcberpr\u00fcfung der Robustheit"},"content":{"rendered":"[vc_row type=”full_width_background” full_screen_row_position=”middle” column_margin=”default” scene_position=”center” text_color=”dark” text_align=”left” bottom_padding=”5%” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none” shape_type=””][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1\/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text]\n

\u00dcberpr\u00fcfung der Robustheit<\/h2>\n[\/vc_column_text][vc_column_text]Die \u00dcberpr\u00fcfung der Robustheit ist ein recht individueller Pr\u00fcfpunkt im Rahmen der Validierung. Sie finden hier eine Tabelle zur Robustheits\u00fcberpr\u00fcfung aus dem Buch “Handbuch Validierung in der Analytik”. Diese Tabelle enth\u00e4lt Pr\u00fcfpunkte, die abh\u00e4ngig von der Matrix, der Methode, dem “Know how” der sp\u00e4teren Anwender usw. in Frage kommen. Wichtige Bemerkung: Nur die individuelle Situation und die konkreten Anforderungen k\u00f6nnen letzten Endes entscheiden, welcher Parameter sinnvollerweise\/notwendigerweise zu \u00fcberpr\u00fcfen w\u00e4ren!<\/p>\n

Diese Tabelle (pdf-Download<\/a>) gilt als Beispiel einer Maximalforderung;\u00a0d<\/strong>ie Auswahl der kritischen Parameter ist abh\u00e4ngig von der Methode individuell festzulegen !<\/strong>[\/vc_column_text][vc_column_text]\n\n\n\n\n\n\n\n\n\n\n\n
Probenvorbereitung:<\/td>\nExtraktionszeit, Ultraschallzeit <\/a>(sowie Geometrie des U-Bades, Wassermenge, Temperatur usw.), Dauer und Art des Aufl\u00f6sens der Probe (Sch\u00fcttelautomat bzw. manuell), Peakfl\u00e4che und -form abh\u00e4ngig von der Konstitution und dem pH-Wert der Probel\u00f6sung, Substanzverlust abh\u00e4ngig vom Filtermaterial, Glasbeschaffenheit, R\u00fchrer, W\u00e4geh\u00fctchen, Inhomogenit\u00e4t der Probe (Matrix-Einfluss, Beschichtung Lack usw.), Lichtempfindlichkeit<\/td>\n<\/tr>\n
Verschleppung:<\/td>\nEinfluss der Septen (Material, Aufbau), des Materials der Injektionsnadel, der Purgefl\u00fcssigkeit, der Kapillaren auf Verschleppung\/Memoryeffekte; Fl\u00e4che(n) mit und ohne S\u00e4ule vergleichen (irreversible Sorption?), Probenl\u00f6sung mit\/ohne Placebo\/Matrix injizieren (Geisterpeaks?)<\/td>\n<\/tr>\n
Flussrate:<\/td>\n\u00b11-2% und Einfluss auf Peakh\u00f6he, -fl\u00e4che \u2013form und Retentionszeit testen (Unterschied Isokrat\/Gradient!)<\/td>\n<\/tr>\n
Gradient:<\/td>\nVerweilvolumen, Design und Volumen der Mischkammer, Mischungsqualit\u00e4t ist abh\u00e4ngig a) von der Viskosit\u00e4t der Eluenten A und B, b) von der Steilheit; Verbesserung der Basislinie etc. falls vorgemischt wird (wichtig!)?<\/td>\n<\/tr>\n
Eluent:<\/td>\n\n
Temperatur:<\/td>\n\u00b11\u00b0C\u2013 aber auch: Nur \u201elinks\u201c oder auch \u201erechts\u201c eingestellt? Einfluss der Geometrie\/des Prinzips (Umluft\/Aluminiumblock<\/a>)?<\/td>\n<\/tr>\n
S\u00e4ule:<\/td>\nCharge, Art des \u201eEinfahrens\u201c bei neuen\/gebrauchten S\u00e4ulen (mit was, Volumen?), S\u00e4ulenstabilit\u00e4t<\/td>\n<\/tr>\n
Detektion:<\/td>\nBeispiel UV: \u03bb \u00b1 2 nm, Zeitkonstante \u00b1 0,1 sec, Bandbreite (\u201eBandwidth\u201c)<\/a> Spaltbreite (\u201eSlit\u201c)<\/a> und Referenzwellenl\u00e4nge beim Dioden-Array\u00a0(1)<\/sup><\/td>\n<\/tr>\n
Datenauswertung:<\/td>\nDatenrateaufnahme (\u201eSample Rate\u201c) \u00b1 2 \u2013 4 Daten\/sec, Threshold-Wert, manuelle\/automatische Integration\u00a0(1)<\/sup><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

(1)<\/sup>: Einfluss auf den Wert selbst \u2013 z. B. Peakfl\u00e4che \u2013 aber auch auf den Vk \u2013 relevant vor allem bei fr\u00fch eluierenden, schmalen, kleinen Peaks![\/vc_column_text][\/vc_column][\/vc_row][vc_row type=”full_width_background” full_screen_row_position=”middle” equal_height=”yes” content_placement=”middle” column_margin=”default” bg_color=”#ee9d34″ scene_position=”center” text_color=”light” text_align=”left” top_padding=”40″ bottom_padding=”40″ overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none” shape_type=””][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1\/2″ tablet_width_inherit=”default” tablet_text_alignment=”center” phone_text_alignment=”center” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_custom_heading text=”Interesse an Pakete?” font_container=”tag:h3|font_size:52|text_align:left|line_height:56px” google_fonts=”font_family:Roboto%20Condensed%3A300%2C300italic%2Cregular%2Citalic%2C700%2C700italic|font_style:700%20bold%20regular%3A700%3Anormal” css=”.vc_custom_1567417573936{padding-left: 25px !important;}”][\/vc_column][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1\/2″ tablet_width_inherit=”default” tablet_text_alignment=”center” phone_text_alignment=”center” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_row_inner column_margin=”default” text_align=”right” css=”.vc_custom_1550215597768{padding-right: 25px !important;}”][vc_column_inner column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” width=”1\/1″ tablet_width_inherit=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][nectar_btn size=”large” button_style=”see-through-3d” color_override=”#ffffff” url=”\/product\/saeulen\/” text=”Paket \u201eS\u00e4ulen\u201c”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"

[vc_row type=”full_width_background” full_screen_row_position=”middle” column_margin=”default” scene_position=”center” text_color=”dark” text_align=”left” bottom_padding=”5%” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none” shape_type=””][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1\/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” overlay_strength=”0.3″ column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text] \u00dcberpr\u00fcfung der Robustheit…<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":3963,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3976","page","type-page","status-publish"],"yoast_head":"\n\u00dcberpr\u00fcfung der Robustheit - 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