{"id":27605,"date":"2021-09-28T12:45:01","date_gmt":"2021-09-28T10:45:01","guid":{"rendered":"https:\/\/kymos.com\/news\/lesperienza-diretta-di-pharmaprogress-con-la-nitrosamina-spingersi-oltre-i-limiti-analitici\/"},"modified":"2025-12-03T19:01:23","modified_gmt":"2025-12-03T18:01:23","slug":"lesperienza-diretta-di-pharmaprogress-con-la-nitrosamina-spingersi-oltre-i-limiti-analitici","status":"publish","type":"post","link":"https:\/\/kymos.com\/it\/news\/lesperienza-diretta-di-pharmaprogress-con-la-nitrosamina-spingersi-oltre-i-limiti-analitici\/","title":{"rendered":"L&#8217;esperienza diretta di Pharmaprogress con la nitrosamina: spingersi oltre i limiti analitici"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 1170px + 20px );margin-left: calc(-20px \/ 2 );margin-right: calc(-20px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:10px;--awb-width-medium:100%;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>Siamo lieti di annunciare che il Dott. Luca Gramaccioni, General Site Manager presso il sito italiano di Kymos <a href=\"https:\/\/kymos.com\/it\/progresso-farmaceutico\/\" data-wpel-link=\"internal\">Pharmaprogress<\/a> , \u00e8 stato invitato a condividere la sua esperienza analitica sulle nitrosammine in un altro webinar, questa volta in occasione del Simposio AFI 2021, ospitato dall&#8217;Associazione Farmaceutici Industria il 24 settembre. In previsione dell&#8217;evento, il Dott. Luca Gramaccioni e il Dott. Massimo Bartolacci, esperto di nitrosammine di Pharmaprogress, condivideranno la loro analisi su come i requisiti normativi si sono evoluti dalla classificazione delle nitrosammine come probabili cancerogeni per l&#8217;uomo nel 2019: <\/p>\n<p>&#8220;Inizialmente, il limite di concentrazione di 0,03 ppm per ciascuna nitrosammina \u00e8 stato identificato dalle autorit\u00e0 come limite per dimostrare l&#8217;assenza di nitrosammina e quindi tale limite \u00e8 diventato l&#8217;attenzione di tutti&#8221;, spiega il Dott. Bartolacci. &#8220;Col tempo, tuttavia, l&#8217;obbligo di collegare il limite di specifica per le nitrosammine alla MDD (dose massima giornaliera) del principio attivo (API) \u00e8 diventato obbligatorio, determinando cos\u00ec una differenziazione dei limiti di specifica e richiedendone una riduzione complessiva&#8221;.  <\/p>\n<p>Inoltre, secondo le attuali linee guida, se i produttori sono in grado di dimostrare che le nitrosammine non superano il 10% dei limiti di specifica, sono esentati dai test di routine sulle nitrosammine nelle analisi di controllo qualit\u00e0 della produzione. A questo punto, il lavoro API \u00e8 completato o quasi completato e le aziende stanno passando alla fase 2 della determinazione delle nitrosammine, in cui le attivit\u00e0 sono incentrate sul progetto finito e, soprattutto, sono necessari metodi analitici pi\u00f9 sensibili per eseguire queste analisi. Fortunatamente, il team del Dott. Bartolacci \u00e8 stato all&#8217;altezza della sfida:  <\/p>\n<p>&#8220;Abbiamo recentemente sviluppato un metodo con un limite inferiore di 0,1 ppb, un nuovo record interno che dimostra il nostro impegno a continuare a spingerci oltre i limiti&#8221;, afferma il Dott. Bartolacci. &#8220;Questa adattabilit\u00e0 per soddisfare i limiti inferiori, unita alla nostra vasta esperienza nel campo delle nitrosammine e alle nostre strutture ben fornite, con strumenti sia LC-MS\/MS che HS-GC-MS disponibili per le analisi sulle nitrosammine, ci ha permesso di adattarci ai mutevoli requisiti normativi e analitici e, in definitiva, di soddisfare le esigenze dei nostri clienti con la stessa qualit\u00e0 e reattivit\u00e0 che si aspettano da noi in passato&#8221;, conclude il Dott. Bartolacci.<\/p>\n<p>Non c&#8217;\u00e8 da stupirsi che il team di Pharmaprogress sia stato invitato a partecipare al Simposio AFI 2021. L&#8217;intervento del Dott. Luca Gramaccioni, intitolato &#8220;Esperienza diretta nell&#8217;affrontare le sfide analitiche della determinazione delle nitrosammine&#8221;, far\u00e0 parte del webinar &#8220;Nitrosammine: dove siamo&#8221;. <\/p>\n<p>Per <strong><a href=\"https:\/\/newaurameeting.it\/prodotto\/live-webinar-simposio-afi-sessione-affari-regolatori\/\" target=\"_blank\" rel=\"noopener\" data-wpel-link=\"external\">maggiori informazioni sul webinar clicca qui<\/a><\/strong> . Sar\u00e0 possibile registrarsi fino alle 17:00 del giorno precedente il webinar. La registrazione \u00e8 gratuita per i Soci AFI e per il personale AIFA, Istituto Superiore di Sanit\u00e0 e Ministero della Salute. La quota di iscrizione per i non Soci AFI \u00e8 di \u20ac 50,00 + IVA 22%.  <\/p>\n<p>Scopri di pi\u00f9 sui nostri <a href=\"https:\/\/kymos.com\/it\/servizi\/analisi-cmc-e-controllo-qualita\/elementari-nitrosammine-e-altre-impurita\/\" data-wpel-link=\"internal\"><b>test sulle impurit\u00e0 elementari, sulle nitrosammine e su altre impurit\u00e0<\/b><\/a> e sul nostro <strong><a href=\"https:\/\/kymos.com\/it\/servizi\/analisi-cmc-e-controllo-qualita\/controllo-di-qualita-delle-piccole-molecole\/\" data-wpel-link=\"internal\">controllo di qualit\u00e0 delle piccole molecole<\/a><\/strong> e <strong><a href=\"https:\/\/kymos.com\/it\/servizi\/analisi-cmc-e-controllo-qualita\/controllo-di-qualita-dei-farmaci-biologici-e-biosimilari\/\" data-wpel-link=\"internal\">sul controllo di qualit\u00e0 dei prodotti biologici e biosimilari<\/a><\/strong> .<\/p>\n<p><a href=\"https:\/\/kymos.com\/it\/contatto\/\" data-wpel-link=\"internal\">Contattaci<\/a> o inviaci un&#8217;e-mail a <strong><a href=\"mailto:commercial@kymos.com?subject=New%20instruments%20at%20Kymos\" data-wpel-link=\"internal\">commercial@kymos.com<\/a><\/strong> .<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":27607,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[263],"tags":[62],"class_list":["post-27605","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gruppo-kymos","tag-joan"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Test delle nitrosammine presso Pharmaprogress<\/title>\n<meta name=\"description\" content=\"Dott. 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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&amp;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? 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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&amp;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? 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