{"id":27198,"date":"2018-11-04T13:31:49","date_gmt":"2018-11-04T12:31:49","guid":{"rendered":"https:\/\/kymos.com\/news\/elementare-verunreinigungen-in-gereinigtem-wasser\/"},"modified":"2025-12-03T18:58:36","modified_gmt":"2025-12-03T17:58:36","slug":"elementare-verunreinigungen-in-gereinigtem-wasser","status":"publish","type":"post","link":"https:\/\/kymos.com\/de\/news\/elementare-verunreinigungen-in-gereinigtem-wasser\/","title":{"rendered":"Elementare Verunreinigungen in gereinigtem Wasser"},"content":{"rendered":"

ICHIn \u00dcbereinstimmung mit der Umsetzungsstrategie des Europ\u00e4ischen Arzneibuchs (Ph. Eur.) f\u00fcr die ICH-Q3D-Leitlinie f\u00fcr elementare Verunreinigungen wurde der Test auf Schwermetalle (2.4.8) gestrichen und ein neuer Abschnitt eingef\u00fcgt: \u201e <\/span><\/span>Wenn gereinigtes Wasser in gro\u00dfen Mengen die f\u00fcr Wasser f\u00fcr Injektionszwecke (0169) vorgeschriebene Leitf\u00e4higkeitsanforderung<\/i> (1,3 \u00b5S\/cm) nicht erf\u00fcllt.<\/em> Es wird eine Risikobewertung gem\u00e4\u00df Kapitel 5.20 \u201eElementare Verunreinigungen\u201c durchgef\u00fchrt. Die Risikobewertung sollte die Rolle des Wassers im Herstellungsprozess ber\u00fccksichtigen, insbesondere wenn Wasser in einem Prozess verwendet wird, aber im Endprodukt nicht mehr vorhanden ist. <\/i><\/span><\/p>\n

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Dieser neue Abschnitt besagt, dass bei einer Leitf\u00e4higkeit des gereinigten Wassers<\/b> von unter 1,3 \u00b5S\/cm bei 25 \u00b0C das Risiko als ausreichend kontrolliert und der Gehalt an elementaren Verunreinigungen so weit reduziert gilt, dass eine Risikobewertung entf\u00e4llt. Liegt die Leitf\u00e4higkeit hingegen zwischen 1,3 \u00b5S\/cm<\/g> (Grenzwert f\u00fcr Wasser f\u00fcr Injektionszwecke) und 5,1 \u00b5S\/cm<\/g> (Grenzwert f\u00fcr gereinigtes Wasser) bei 25 \u00b0C, sollte eine Risikobewertung durchgef\u00fchrt werden, um die im Wasser vorhandenen elementaren Verunreinigungen und deren potenzielle Quellen genauer zu bestimmen. In solchen F\u00e4llen ist die Untersuchung aller 24 elementaren Verunreinigungen die beste Methode, um fundierte Schlussfolgerungen zu ziehen. <\/span><\/p>\n

Heutzutage ist die ICP-MS die Technologie der Wahl, um die f\u00fcr bestimmte Verunreinigungen erforderliche niedrige Quantifizierungsgrenze zu erreichen und die M\u00f6glichkeit zu bieten, mit einer einzigen Injektion Ergebnisse f\u00fcr alle Verunreinigungen unter Verwendung einer allgemein validierten Methode zu erhalten.<\/span><\/p>\n

Eine allgemeine Methode sollte anhand von mindestens drei repr\u00e4sentativen Proben gereinigten Wassers validiert werden, um die gesamte potenzielle Variabilit\u00e4t abzudecken. Die Auswahlkriterien sollten Parameter wie unterschiedliche Tage, unterschiedliche Anwendungsorten und alle anderen relevanten Umst\u00e4nde umfassen. Die nachweisbare Bestimmungsgrenze (LOQ) in unseren Laboren kann Konzentrationen erreichen, die 30 % der PDE entsprechen, berechnet unter Ber\u00fccksichtigung einer oralen Verabreichung und einer maximalen Tagesdosis von 4 Litern. <\/span><\/p>\n

Im Einzelnen sollte die Analysemethode h\u00f6chstens in der Lage sein, nachzuweisen, dass die elementaren Verunreinigungen unterhalb der folgenden Konzentrationen liegen, und somit die Anforderungen der ICH Q3D-Leitlinie erf\u00fcllen.<\/span><\/p>\n

Grenzwerte f\u00fcr elementare Verunreinigungen:<\/strong><\/span><\/h3>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

EI<\/span><\/p>\n<\/td>\n

\n

Bestimmungsgrenze (ppb)<\/span><\/p>\n<\/td>\n

\n

EI<\/span><\/p>\n<\/td>\n

\n

Bestimmungsgrenze (ppb)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

CD<\/span><\/p>\n<\/td>\n

\n

0.375<\/span><\/p>\n<\/td>\n

\n

Rh<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Pb<\/span><\/p>\n<\/td>\n

\n

0.375<\/span><\/p>\n<\/td>\n

\n

Ru<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Als<\/span><\/p>\n<\/td>\n

\n

1.125<\/span><\/p>\n<\/td>\n

\n

Se<\/span><\/p>\n<\/td>\n

\n

11.250<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Quecksilber<\/span><\/p>\n<\/td>\n

\n

2.250<\/span><\/p>\n<\/td>\n

\n

Landwirtschaft<\/span><\/p>\n<\/td>\n

\n

11.250<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Co<\/span><\/p>\n<\/td>\n

\n

3.750<\/span><\/p>\n<\/td>\n

\n

Pt<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

V<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n

\n

Li<\/span><\/p>\n<\/td>\n

\n

41.250<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Ni<\/span><\/p>\n<\/td>\n

\n

15.000<\/span><\/p>\n<\/td>\n

\n

Sb<\/span><\/p>\n<\/td>\n

\n

90.000<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Tl<\/span><\/p>\n<\/td>\n

\n

0.600<\/span><\/p>\n<\/td>\n

\n

Ba<\/span><\/p>\n<\/td>\n

\n

105.000<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Au<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n

\n

Mo<\/span><\/p>\n<\/td>\n

\n

225.000<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Pd<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n

\n

Cu<\/span><\/p>\n<\/td>\n

\n

225.000<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Ir<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n

\n

Sn<\/span><\/p>\n<\/td>\n

\n

450.000<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Os<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n

\n

Cr<\/span><\/p>\n<\/td>\n

\n

825.000<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>

Wenn Sie mehr \u00fcber unsere Dienstleistungen im Bereich der Element-, Nitrosamin- und sonstigen Verunreinigungsanalyse erfahren m\u00f6chten , klicken Sie hier.<\/a><\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":27199,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[266],"tags":[],"class_list":["post-27198","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc"],"acf":[],"yoast_head":"\nElementare Verunreinigungen in gereinigtem Wasser | Kymos<\/title>\n<meta name=\"description\" content=\"Erfahren Sie mehr \u00fcber die Pr\u00fcfung von elementaren Verunreinigungen in gereinigtem Wasser und wie ICP-MS Ihnen dabei helfen kann, die erforderliche niedrige Quantifizierungsgrenze zu erreichen.\" \/>\n<meta name=\"robots\" content=\"index, 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Dou","image":{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/secure.gravatar.com\/avatar\/263d7ff1c7891f5821a5075a1a362a1e513db5931dc882455e887fe1c1ccf924?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/263d7ff1c7891f5821a5075a1a362a1e513db5931dc882455e887fe1c1ccf924?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/263d7ff1c7891f5821a5075a1a362a1e513db5931dc882455e887fe1c1ccf924?s=96&d=mm&r=g","caption":"Joan Puig de Dou"},"description":"Active in the pharmaceutical marketing for over 30 years President of CataloniaBIO&HealthTech CEO and Qualified Person at Kymos Leader of Kymos team, guaranteeing a trustable, ethical and scientific correct editorial publications. Experience Joan Puig de Dou started his career at Laboratorios Menarini first as scientist later as Qualified Person and finally as Operations General Manager. 2010 he entered Kymos where he became CEO in 2015. 2022 Joan Puig de Dou was elected as president of CataloniaBio&HealthTech to represent the Catalonian biotech industry nationally and internationally. Expertise Joan Puig de Dou has extensive experience in writing scientific content adopting a didactic approach that fits any reader\u2019s level of expertise. He publishes regularely on Kymos\u2019 webpage, social media and in the specialized press. Education He graduated from Universitat de Barcelona as Pharmacist and from IESE Business School\u2019s Programa Diecci\u00f3n General (PDG) Want to know him better? Read his interview in PharmaBoardrooom in January 2019 and more about his presidency of CataloniaBio at Parc Sc\u00edentific de Barcelona.","url":"https:\/\/kymos.com\/de\/news\/author\/joan-puig-de-dou\/"}]}},"_links":{"self":[{"href":"https:\/\/kymos.com\/de\/wp-json\/wp\/v2\/posts\/27198","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kymos.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kymos.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kymos.com\/de\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/kymos.com\/de\/wp-json\/wp\/v2\/comments?post=27198"}],"version-history":[{"count":0,"href":"https:\/\/kymos.com\/de\/wp-json\/wp\/v2\/posts\/27198\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kymos.com\/de\/wp-json\/wp\/v2\/media\/27199"}],"wp:attachment":[{"href":"https:\/\/kymos.com\/de\/wp-json\/wp\/v2\/media?parent=27198"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kymos.com\/de\/wp-json\/wp\/v2\/categories?post=27198"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kymos.com\/de\/wp-json\/wp\/v2\/tags?post=27198"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}