{"id":23171,"date":"2021-09-28T12:45:01","date_gmt":"2021-09-28T10:45:01","guid":{"rendered":"https:\/\/kymos.com\/news\/la-experiencia-de-primera-mano-de-pharmaprogress-con-nitrosaminas-ampliando-los-limites-analiticos\/"},"modified":"2025-08-07T20:33:48","modified_gmt":"2025-08-07T18:33:48","slug":"la-experiencia-de-primera-mano-de-pharmaprogress-con-nitrosaminas-ampliando-los-limites-analiticos","status":"publish","type":"post","link":"https:\/\/kymos.com\/es\/news\/la-experiencia-de-primera-mano-de-pharmaprogress-con-nitrosaminas-ampliando-los-limites-analiticos\/","title":{"rendered":"La experiencia de primera mano de Pharmaprogress con nitrosaminas: ampliando los l\u00edmites anal\u00edticos"},"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>Nos complace anunciar que el Dr. Luca Gramaccioni, Director General de la Planta Italiana de Kymos <a href=\"https:\/\/kymos.com\/es\/progreso-farmaceutico\/\" data-wpel-link=\"internal\">Pharmaprogress<\/a> , ha sido invitado a compartir su experiencia anal\u00edtica sobre nitrosaminas en otro seminario web, en esta ocasi\u00f3n durante el Simposio AFI 2021, organizado por la Associazione Farmaceutici Industria el 24 de septiembre. A la espera del evento, \u00e9l y el Dr. Massimo Bartolacci, experto en nitrosaminas de Pharmaprogress, comparten su perspectiva sobre la evoluci\u00f3n de los requisitos regulatorios desde la clasificaci\u00f3n de las nitrosaminas como probables carcin\u00f3genos humanos en 2019. <\/p>\n<p>\u201cAl principio, las autoridades identificaron el l\u00edmite de concentraci\u00f3n de 0,03 ppm para cada nitrosamina como el l\u00edmite para demostrar la ausencia de nitrosamina, y por lo tanto, dicho l\u00edmite se convirti\u00f3 en la prioridad\u201d, explica el Dr. Bartolacci. \u201cSin embargo, con el tiempo, se hizo obligatorio vincular el l\u00edmite de especificaci\u00f3n para las nitrosaminas a la dosis diaria m\u00e1xima (DDM) del ingrediente activo (API), lo que provoc\u00f3 una diferenciaci\u00f3n de los l\u00edmites de especificaci\u00f3n y exigi\u00f3 su reducci\u00f3n general\u201d.  <\/p>\n<p>Adem\u00e1s, seg\u00fan las directrices actuales, si los fabricantes pueden demostrar que las nitrosaminas no superan el 10 % de los l\u00edmites de especificaci\u00f3n, quedan exentos de las pruebas rutinarias de nitrosaminas en sus an\u00e1lisis de control de calidad de fabricaci\u00f3n. En este punto, el trabajo de API est\u00e1 finalizado o casi finalizado y las empresas pasan a la etapa 2 de la determinaci\u00f3n de nitrosaminas, donde las actividades se centran en el proyecto finalizado y, lo m\u00e1s importante, se requieren m\u00e9todos anal\u00edticos m\u00e1s sensibles para realizar estos an\u00e1lisis. Afortunadamente, el equipo del Dr. Bartolacci estuvo a la altura del reto:  <\/p>\n<p>\u00abRecientemente desarrollamos un m\u00e9todo con un l\u00edmite inferior de 0,1 ppb, un nuevo r\u00e9cord interno que ilustra nuestro compromiso de seguir superando los l\u00edmites\u00bb, afirma el Dr. Bartolacci. \u00abEsta adaptabilidad para cumplir con los l\u00edmites inferiores, combinada con nuestra amplia experiencia en nitrosaminas y nuestras instalaciones bien equipadas, con instrumentos LC-MS\/MS y HS-GC-MS disponibles para el an\u00e1lisis de nitrosaminas, nos ha permitido adaptarnos a los cambiantes requisitos normativos y anal\u00edticos y, en \u00faltima instancia, satisfacer las necesidades de nuestros clientes con la misma calidad y capacidad de respuesta que esperaban de nosotros\u00bb, concluye el Dr. Bartolacci.<\/p>\n<p>No es de extra\u00f1ar que el equipo de Pharmaprogress haya sido invitado a participar en el Simposio AFI 2021. La charla del Dr. Luca Gramaccioni, titulada \u00abExperiencia directa abordando los desaf\u00edos anal\u00edticos de la determinaci\u00f3n de nitrosaminas\u00bb, formar\u00e1 parte del seminario web \u00abNitrosaminas: D\u00f3nde estamos\u00bb. <\/p>\n<p>Para <strong><a href=\"https:\/\/newaurameeting.it\/prodotto\/live-webinar-simposio-afi-sessione-affari-regolatori\/\" target=\"_blank\" rel=\"noopener\" data-wpel-link=\"external\">m\u00e1s informaci\u00f3n sobre el seminario web, haga clic aqu\u00ed<\/a><\/strong> . La inscripci\u00f3n es gratuita para miembros de AFI y personal de AIFA, del Instituto Superior de Salud y del Ministerio de Salud. La cuota de inscripci\u00f3n para quienes no sean miembros de AFI es de 50 \u20ac + IVA del 22 %.  <\/p>\n<p>Obtenga m\u00e1s informaci\u00f3n sobre nuestras <a href=\"https:\/\/kymos.com\/es\/servicios\/analisis-y-control-de-calidad-de-cmc\/elementales-nitrosaminas-y-otras-impurezas\/\" data-wpel-link=\"internal\"><b>pruebas de elementos, nitrosaminas y otras impurezas<\/b><\/a> y sobre nuestro <strong><a href=\"https:\/\/kymos.com\/es\/servicios\/analisis-y-control-de-calidad-de-cmc\/control-de-calidad-de-moleculas-pequenas\/\" data-wpel-link=\"internal\">control de calidad de mol\u00e9culas peque\u00f1as<\/a><\/strong> y <strong><a href=\"https:\/\/kymos.com\/es\/servicios\/analisis-y-control-de-calidad-de-cmc\/control-de-calidad-de-productos-biologicos-y-biosimilares\/\" data-wpel-link=\"internal\">control de calidad de productos biol\u00f3gicos y biosimilares<\/a><\/strong> .<\/p>\n<p><a href=\"https:\/\/kymos.com\/es\/contacto\/\" data-wpel-link=\"internal\">Cont\u00e1ctanos<\/a> o env\u00edanos un correo electr\u00f3nico a <strong><a href=\"mailto:comercial@kymos.com?subject=Nuevos%20instrumentos%20en%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":21977,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[184],"tags":[62],"class_list":["post-23171","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-grupo-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>Pruebas de nitrosaminas en Pharmaprogress<\/title>\n<meta name=\"description\" content=\"Dr. Luca Gramaccioni, Gerente de Sitio de Pharmaprogress: Experiencia de primera mano con nitrosaminas: 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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? 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\\\/es\\\/news\\\/author\\\/joan-puig-de-dou\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Pruebas de nitrosaminas en Pharmaprogress","description":"Dr. Luca Gramaccioni, Gerente de Sitio de Pharmaprogress: Experiencia de primera mano con nitrosaminas: Ampliando los l\u00edmites anal\u00edticos","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/kymos.com\/es\/news\/la-experiencia-de-primera-mano-de-pharmaprogress-con-nitrosaminas-ampliando-los-limites-analiticos\/","og_locale":"es_ES","og_type":"article","og_title":"Pruebas de nitrosaminas en Pharmaprogress","og_description":"Dr. Luca Gramaccioni, Gerente de Sitio de Pharmaprogress: Experiencia de 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Dou","image":{"@type":"ImageObject","inLanguage":"es","@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&amp;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&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? 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\/es\/news\/author\/joan-puig-de-dou\/"}]}},"_links":{"self":[{"href":"https:\/\/kymos.com\/es\/wp-json\/wp\/v2\/posts\/23171","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kymos.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kymos.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kymos.com\/es\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/kymos.com\/es\/wp-json\/wp\/v2\/comments?post=23171"}],"version-history":[{"count":0,"href":"https:\/\/kymos.com\/es\/wp-json\/wp\/v2\/posts\/23171\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kymos.com\/es\/wp-json\/wp\/v2\/media\/21977"}],"wp:attachment":[{"href":"https:\/\/kymos.com\/es\/wp-json\/wp\/v2\/media?parent=23171"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kymos.com\/es\/wp-json\/wp\/v2\/categories?post=23171"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kymos.com\/es\/wp-json\/wp\/v2\/tags?post=23171"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}