{"id":27186,"date":"2018-11-04T13:31:49","date_gmt":"2018-11-04T12:31:49","guid":{"rendered":"https:\/\/kymos.com\/news\/impurita-elementari-nellacqua-purificata\/"},"modified":"2025-12-03T18:58:36","modified_gmt":"2025-12-03T17:58:36","slug":"impurita-elementari-nellacqua-purificata","status":"publish","type":"post","link":"https:\/\/kymos.com\/it\/news\/impurita-elementari-nellacqua-purificata\/","title":{"rendered":"Impurit\u00e0 elementari nell’acqua purificata"},"content":{"rendered":"

IOIn linea con la strategia di implementazione della Farmacopea Europea per la linea guida ICH Q3D per le impurit\u00e0 elementari, il test per i metalli pesanti (2.4.8) \u00e8 stato eliminato ed \u00e8 inclusa una nuova sezione: \u201c <\/span><\/span>Se l’acqua purificata in massa non soddisfa il requisito di conduttivit\u00e0 prescritto per l’acqua per preparazioni iniettabili (0169) in massa<\/i> (1,3 \u00b5S\/cm),<\/em> viene effettuata una valutazione del rischio secondo il capitolo generale 5.20 Impurit\u00e0 elementari. La valutazione del rischio dovrebbe considerare il ruolo dell’acqua nel processo di fabbricazione, in particolare quando l’acqua viene utilizzata in un processo ma non \u00e8 pi\u00f9 presente nel prodotto finale.” <\/i><\/span><\/p>\n

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Questa nuova sezione stabilisce che se l’ acqua purificata<\/b> presenta un livello di conducibilit\u00e0 inferiore a 1,3 \u00b5S\/cm a 25 \u00b0C, il rischio \u00e8 costantemente controllato e il contenuto di impurit\u00e0 elementari \u00e8 sufficientemente ridotto da evitare l’analisi di valutazione del rischio. Pertanto, quando le conducibilit\u00e0 sono comprese tra 1,3 \u00b5S\/cm<\/b> (limite dell’acqua per iniezione) e 5,1 \u00b5S\/cm<\/b> (limite dell’acqua purificata) a 25 \u00b0C, \u00e8 necessario condurre una valutazione del rischio per avere una migliore conoscenza delle impurit\u00e0 elementari presenti nell’acqua e delle loro potenziali fonti. In tali casi, uno screening di tutte le 24 impurit\u00e0 elementari \u00e8 il modo migliore per ottenere conclusioni adeguate. <\/span><\/p>\n

Oggigiorno, l’ICP-MS \u00e8 la tecnologia di elezione per raggiungere il basso livello di quantificazione richiesto per alcune impurit\u00e0 e la possibilit\u00e0 di ottenere risultati per tutte le impurit\u00e0 utilizzando un metodo generale convalidato in una singola iniezione.<\/span><\/p>\n

\u00c8 necessario convalidare un metodo generale che includa almeno 3 campioni rappresentativi di acqua purificata, coprendo tutta la potenziale variabilit\u00e0. I criteri di selezione dovrebbero includere parametri quali giorni diversi, diversi punti di utilizzo e qualsiasi altra circostanza che possa essere rilevante. Il LOQ dimostrabile nei nostri laboratori pu\u00f2 raggiungere concentrazioni equivalenti al 30% di PDE, calcolate considerando una via di somministrazione orale e 4 l di dose giornaliera massima. <\/span><\/p>\n

Nello specifico, il metodo analitico dovrebbe al massimo essere in grado di dimostrare che le impurit\u00e0 elementari sono inferiori alle seguenti concentrazioni, soddisfacendo i requisiti della linea guida ICH Q3D.<\/span><\/p>\n

Limiti delle impurit\u00e0 elementari:<\/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

Quantit\u00e0 minima di riferimento (ppb)<\/span><\/p>\n<\/td>\n

\n

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

\n

Quantit\u00e0 minima di riferimento (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

Piombo<\/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

COME<\/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

Mercurio<\/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

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

\n

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

\n

Punto<\/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

Io<\/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>

Per saperne di pi\u00f9 sui nostri servizi relativi a elementi, nitrosammine e altre impurit\u00e0 clicca qui.<\/a><\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":27188,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[264],"tags":[],"class_list":["post-27186","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc"],"acf":[],"yoast_head":"\nImpurit\u00e0 elementari nell'acqua purificata | Kymos<\/title>\n<meta name=\"description\" content=\"Scopri di pi\u00f9 sui test delle impurit\u00e0 elementari nell'acqua purificata e su come l'ICP-MS pu\u00f2 aiutarti a raggiungere il basso livello di quantificazione richiesto.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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Dou","image":{"@type":"ImageObject","inLanguage":"it-IT","@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\/it\/news\/author\/joan-puig-de-dou\/"}]}},"_links":{"self":[{"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/posts\/27186","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/comments?post=27186"}],"version-history":[{"count":0,"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/posts\/27186\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/media\/27188"}],"wp:attachment":[{"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/media?parent=27186"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/categories?post=27186"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/tags?post=27186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}