{"id":27351,"date":"2020-05-30T11:01:22","date_gmt":"2020-05-30T09:01:22","guid":{"rendered":"https:\/\/kymos.com\/news\/analisi-delle-impurita-elementari-anticipare-le-esigenze-dei-nostri-clienti-prima-che-ce-le-chiedano\/"},"modified":"2025-12-03T18:59:52","modified_gmt":"2025-12-03T17:59:52","slug":"analisi-delle-impurita-elementari-anticipare-le-esigenze-dei-nostri-clienti-prima-che-ce-le-chiedano","status":"publish","type":"post","link":"https:\/\/kymos.com\/it\/news\/analisi-delle-impurita-elementari-anticipare-le-esigenze-dei-nostri-clienti-prima-che-ce-le-chiedano\/","title":{"rendered":"Analisi delle impurit\u00e0 elementari: anticipare le esigenze dei nostri clienti prima che ce le chiedano"},"content":{"rendered":"

La Farmacopea Europea ha recepito le linee guida ICH Q3D nel giugno 2017, stabilendo la necessit\u00e0 di valutare la presenza di potenziali impurezze elementari in tutti i prodotti farmaceutici. Ora le linee guida saranno estese anche ai prodotti per uso veterinario. <\/span><\/h3>\n
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Parliamo con la nostra esperta in impurit\u00e0 elementari<\/a> , Gemma Solsona, che ci aggiorna sugli ultimi sviluppi del settore. Gemma vanta quasi un decennio di esperienza nel settore farmaceutico e dirige un reparto storicamente legato ai cambiamenti normativi. <\/span><\/p>\n

“Per quanto riguarda i cambiamenti futuri, la raccomandazione generale \u00e8 di prepararsi in anticipo”,<\/em> afferma.<\/span><\/p>\n

Come si \u00e8 preparata KYMOS a questa valutazione?<\/strong><\/span>
\nNel 2017 e nel 2018 si \u00e8 registrato un importante aumento della domanda da parte delle aziende di sottoporre i propri prodotti farmaceutici a test, in concomitanza con l’implementazione delle linee guida ICH Q3D per le impurezze elementari nei prodotti farmaceutici. Gemma e il suo team vantano un’esperienza con oltre 600 prodotti diversi. Hanno eseguito analisi approfondite con spettrometria di massa a plasma accoppiato ionico (ICP-MS) all’avanguardia, che consente limiti di rilevazione pi\u00f9 bassi e screening multi-elementari simultanei, nonch\u00e9 con spettrometria di assorbimento atomico (AAS). Questa vasta esperienza ha aiutato KYMOS a sviluppare un solido reparto dedicato alle impurezze elementari. <\/span><\/p>\n

“Abbiamo sviluppato una disciplina interna per lo screening delle impurit\u00e0 elementari, per adattarci rapidamente al prodotto del cliente, ottenendo un’analisi rapida e conveniente”,<\/em> afferma Gemma.<\/span><\/p>\n

In che modo Gemma e il suo team possono aiutarti?<\/strong><\/span>
\nIl team di Gemma \u00e8 pronto a fornire soluzioni per tre nuove sfide:<\/span><\/p>\n

    \n
  1. A met\u00e0 del 2019 \u00e8 stato deciso di ampliare l’ambito di applicazione dell’ICH Q3D per includere anche i farmaci veterinari. KYMOS ha acquisito preziose conoscenze nell’analisi di prodotti farmaceutici per uso umano, ma \u00e8 pienamente trasferibile al settore della medicina veterinaria e pertanto il servizio \u00e8 gi\u00e0 disponibile. <\/span><\/li>\n
  2. KYMOS offre anche un nuovo servizio convalidato, basato sul metodo compendiale “Purified Water” (04\/2018:0008) recentemente implementato, per il controllo delle impurit\u00e0 elementari nell’acqua utilizzata di routine durante la produzione della stragrande maggioranza dei prodotti (formulazioni liquide o altro). Il metodo completamente convalidato consente al cliente di saltare la fase di convalida, costosa e dispendiosa in termini di tempo, beneficiando cos\u00ec di un’offerta pi\u00f9 competitiva. <\/span><\/li>\n
  3. KYMOS sta sviluppando internamente un metodo ICP-MS per sostituire i metodi colorimetrici compendiali come la determinazione dell’arsenico.<\/span><\/li>\n<\/ol>\n

    \u201cAbbiamo tecniche all\u2019avanguardia e, seguendo le ultime normative, ci permettono di anticipare le esigenze del cliente\u201d,<\/em> aggiunge Gemma.<\/span><\/p>\n

    E allora, cosa succeder\u00e0 a Gemma e al suo ambizioso dipartimento? <\/strong><\/span>
    \n“Questo \u00e8 un reparto entusiasta e sempre guidato da un forte impegno verso il miglioramento personale”.<\/em> Gemma e il suo team hanno lavorato per ridurre i tempi di consegna: “Siamo pronti a garantire un tempo di consegna di 2-3 settimane per un rapporto di screening e risultati per scopi di controllo qualit\u00e0 tra 5 e 10 giorni”.<\/em><\/span><\/p>\n

    I prossimi anni saranno cruciali, poich\u00e9 il team di Gemma continuer\u00e0 a implementare metodi di test completi, sviluppando al contempo nuovi standard conformi ai farmaci per uso umano. Visti i risultati ottenuti finora, siamo pienamente certi che Gemma e il suo team porteranno avanti questo progetto con efficienza e professionalit\u00e0. <\/span><\/p>\n

    <\/span><\/p>\n

    Per maggiori informazioni su KYMOS, sui servizi generali per le impurit\u00e0 elementari<\/a> e sull’acqua purificata<\/a> , potete contattarci all’indirizzo commercial@kymos.com<\/a> .<\/a><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":27353,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[264],"tags":[],"class_list":["post-27351","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc"],"acf":[],"yoast_head":"\nAnalisi delle impurit\u00e0 elementari - Kymos<\/title>\n<meta name=\"description\" content=\"CRO per l'analisi delle impurit\u00e0 elementari. 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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\/27351","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=27351"}],"version-history":[{"count":0,"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/posts\/27351\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/media\/27353"}],"wp:attachment":[{"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/media?parent=27351"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/categories?post=27351"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kymos.com\/it\/wp-json\/wp\/v2\/tags?post=27351"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}