{"id":22709,"date":"2018-11-04T13:31:49","date_gmt":"2018-11-04T12:31:49","guid":{"rendered":"https:\/\/kymos.com\/news\/impureses-elementals-en-aigua-purificada\/"},"modified":"2025-08-07T09:37:53","modified_gmt":"2025-08-07T07:37:53","slug":"impureses-elementals-en-aigua-purificada","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/impureses-elementals-en-aigua-purificada\/","title":{"rendered":"Impureses elementals en aigua purificada"},"content":{"rendered":"

JoD’acord amb l’estrat\u00e8gia d’implementaci\u00f3 de la Farmacologia Europea per a la guia ICH Q3D per a impureses elementals, s’ha eliminat la prova de metalls pesants (2.4.8) i s’ha incl\u00f2s una nova secci\u00f3: ” <\/span><\/span>Si l’aigua purificada a granel no compleix el requisit de conductivitat prescrit per a l’aigua per a injeccions (0169) a granel<\/i> (1,3 \u00b5S\/cm),<\/em> es duu a terme una avaluaci\u00f3 de riscos d’acord amb el cap\u00edtol general 5.20 Impureses elementals. L’avaluaci\u00f3 de riscos ha de tenir en compte el paper de l’aigua en el proc\u00e9s de fabricaci\u00f3, en particular quan s’utilitza aigua en un proc\u00e9s per\u00f2 ja no \u00e9s present en el producte final. <\/i><\/span><\/p>\n

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Aquesta nova secci\u00f3 estableix que si l’ aigua purificada<\/b> presenta un nivell de conductivitat inferior a 1,3 \u00b5S\/cm a 25\u00baC, el risc es controla de manera consistent i el contingut d’impureses elementals es redueix prou per evitar l’an\u00e0lisi d’avaluaci\u00f3 de riscos. Per tant, quan les conductivitats es troben entre 1,3 \u00b5S\/cm<\/b> (l\u00edmit d’aigua per a injecci\u00f3) i 5,1 \u00b5S\/cm<\/b> (l\u00edmit d’aigua purificada) a 25\u00baC, s’ha de dur a terme l’avaluaci\u00f3 de riscos per tenir un millor coneixement de les impureses elementals presents a l’aigua i les seves possibles fonts. En aquests casos, una an\u00e0lisi de les 24 impureses elementals \u00e9s la millor manera d’obtenir conclusions adequades. <\/span><\/p>\n

Avui dia, l’ICP-MS \u00e9s la tecnologia electa per assolir el baix nivell de quantificaci\u00f3 necessari per a certes impureses i la possibilitat d’obtenir resultats per a totes les impureses utilitzant un m\u00e8tode general validat en una sola injecci\u00f3.<\/span><\/p>\n

Cal validar un m\u00e8tode general que inclogui almenys 3 mostres representatives d’aigua purificada, que cobreixin tota la variabilitat potencial. Els criteris de selecci\u00f3 han d’incloure par\u00e0metres com ara dies diferents, punts d’\u00fas diferents i qualsevol altra circumst\u00e0ncia que pugui ser rellevant. El LOQ demostrable als nostres laboratoris pot assolir concentracions equivalents al 30% de la PDE calculada tenint en compte una via d’administraci\u00f3 oral i 4 L de dosi m\u00e0xima di\u00e0ria. <\/span><\/p>\n

Espec\u00edficament, el m\u00e8tode anal\u00edtic com a m\u00e0xim hauria de ser capa\u00e7 de demostrar que les impureses elementals s\u00f3n inferiors a les concentracions seg\u00fcents, complint els requisits de la guia ICH Q3D.<\/span><\/p>\n

L\u00edmits d’impureses elementals:<\/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

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

\n

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

\n

LOQ (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

Com<\/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

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

\n

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

\n

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

\n

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

\n

Companyia<\/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>

If you want to learn more about our elemental, nitrosamines and other impurity services click here.<\/a><\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":15008,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97],"tags":[],"class_list":["post-22709","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-ca"],"acf":[],"yoast_head":"\nImpureses elementals en aigua purificada | Kymos<\/title>\n<meta name=\"description\" content=\"Apr\u00e8n m\u00e9s sobre les proves d'impureses elementals en aigua purificada i com l'ICP-MS et pot ajudar a assolir el baix nivell de quantificaci\u00f3 necessari.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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Dou","image":{"@type":"ImageObject","inLanguage":"ca","@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\/ca\/news\/author\/joan-puig-de-dou\/"}]}},"_links":{"self":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/posts\/22709","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/comments?post=22709"}],"version-history":[{"count":0,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/posts\/22709\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/media\/15008"}],"wp:attachment":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/media?parent=22709"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/categories?post=22709"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/tags?post=22709"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}