{"id":22738,"date":"2021-09-28T12:45:01","date_gmt":"2021-09-28T10:45:01","guid":{"rendered":"https:\/\/kymos.com\/news\/experiencia-de-primera-ma-amb-la-nitrosamina-de-pharmaprogress-superant-els-limits-de-lanalisi\/"},"modified":"2025-08-07T09:43:19","modified_gmt":"2025-08-07T07:43:19","slug":"experiencia-de-primera-ma-amb-la-nitrosamina-de-pharmaprogress-superant-els-limits-de-lanalisi","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/experiencia-de-primera-ma-amb-la-nitrosamina-de-pharmaprogress-superant-els-limits-de-lanalisi\/","title":{"rendered":"Experi\u00e8ncia de primera m\u00e0 amb la nitrosamina de Pharmaprogress: superant els l\u00edmits de l&#8217;an\u00e0lisi"},"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>We are pleased to announce that Dr Luca Gramaccioni, General Site Manager at Kymos Italian Site <a href=\"https:\/\/kymos.com\/ca\/pharmaprogress\/\" data-wpel-link=\"internal\">Pharmaprogress<\/a>, has been asked to share his analytical experience on nitrosamines in yet another webinar \u2013 this time the AFI Symposium 2021 hosted by the Associazione Farmaceutici Industria on September 24th. In anticipation for the event, he and Dr Massimo Bartolacci, Pharmaprogress\u2019 nitrosamine expert, share their insight into how regulatory requirements have evolved since the classification of nitrosamines as probable human carcinogens back in 2019:<\/p>\n<p>\u201cAt first the concentration limit of 0.03 ppm for each nitrosamine was identified by the authorities as the limit to demonstrate the absence of nitrosamine and therefore that limit became everybody\u2019s focus.\u201d Dr Bartolacci explains. \u201cOver time, however, the requirement to link the specification limit for nitrosamines to the MDD (maximum daily dose) of the active ingredient (API) became mandatory, thus causing a differentiation of the specification limits and calling for their overall reduction.&#8221;<\/p>\n<p>In addition, under current guidelines, if manufacturers are able to prove that nitrosamines do not exceed 10% of the limits of specification, they are exempt from routine nitrosamines testing in their manufacturing quality control analysis. At this point API work is completed or near completion and companies are moving to step 2 of nitrosamine determination where activities are centred on the finished project and, most importantly, more sensitive analytical methods are required to perform these analyses. Fortunately, Dr Bartolacci\u2019s team was up to the challenge:<\/p>\n<p>&#8220;We recently developed a method with a lower limit of 0.1 ppb, a new in-house record which illustrates our commitment to keep pushing the envelope.\u201d Dr Bartolacci states. \u201cThis adaptability to meet lower limit levels, combined with our extensive nitrosamine experience and our well provided facilities, with both LC-MS\/MS and HS-GC-MS instruments available for nitrosamine work, has made it possible for us to adapt to changing regulatory and analytical requirements and ultimately satisfy our customer needs with the same quality and responsiveness they have come to expect from us in the past.\u201d Dr Bartolacci concludes.<\/p>\n<p>No wonder that the Pharmaprogress team has been invited to participate at the AFI 2021 Symposium. Dr Luca Gramaccioni\u2019s talk, titled &#8220;First-hand experience addressing analytical challenges of nitrosamines determination&#8221; will be part of the &#8220;Nitrosamines: Where we are&#8221; webinar.<\/p>\n<p>For <strong><a href=\"https:\/\/newaurameeting.it\/prodotto\/live-webinar-simposio-afi-sessione-affari-regolatori\/\" target=\"_blank\" rel=\"noopener\" data-wpel-link=\"external\">more information about the webinar click here<\/a><\/strong>.It will be possible to register until 5.00 pm on the day before the webinar. Registration is free for AFI Members and staff from AIFA or the Higher Institute of Health and the Ministry of Health. Registration fees for non-AFI members are \u20ac50.0 + VAT 22%.<\/p>\n<p>Learn more about our <a href=\"https:\/\/kymos.com\/ca\/serveis\/cmc-analisi-i-control-de-qualitat\/elementals-nitrosamines-i-altres-impureses\/\" data-wpel-link=\"internal\"><b>Elemental, nitrosamines and other impurities testing <\/b><\/a>and about our <strong><a href=\"https:\/\/kymos.com\/ca\/serveis\/cmc-analisi-i-control-de-qualitat\/control-de-qualitat-de-petites-molecules\/\" data-wpel-link=\"internal\">Quality control of small molecules <\/a><\/strong>and <strong><a href=\"https:\/\/kymos.com\/ca\/serveis\/cmc-analisi-i-control-de-qualitat\/control-de-qualitat-de-productes-biologics-i-biosimilars\/\" data-wpel-link=\"internal\">Quality control of biologics and biosimilars<\/a><\/strong>.<\/p>\n<p><a href=\"https:\/\/kymos.com\/ca\/contacte\/\" data-wpel-link=\"internal\">Contact us<\/a> or send us an email to <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":15269,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[107],"tags":[62],"class_list":["post-22738","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-kymos-group-ca","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>Proves de nitrosamina a Pharmaprogress<\/title>\n<meta name=\"description\" content=\"Dr. Luca Gramaccioni, gerent de planta de Pharmaprogress: Experi\u00e8ncia de primera m\u00e0 amb nitrosamines: superant els l\u00edmits de l&#039;an\u00e0lisi\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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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&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\/ca\/news\/author\/joan-puig-de-dou\/"}]}},"_links":{"self":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/posts\/22738","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=22738"}],"version-history":[{"count":0,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/posts\/22738\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/media\/15269"}],"wp:attachment":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/media?parent=22738"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/categories?post=22738"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/tags?post=22738"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}