{"id":27309,"date":"2020-04-21T10:58:41","date_gmt":"2020-04-21T08:58:41","guid":{"rendered":"https:\/\/kymos.com\/news\/depistage-des-nitrosamines-elargissez-le-champ-dinvestigation-aujourdhui-reduisez-les-couts-demain\/"},"modified":"2025-12-03T18:59:26","modified_gmt":"2025-12-03T17:59:26","slug":"depistage-des-nitrosamines-elargissez-le-champ-dinvestigation-aujourdhui-reduisez-les-couts-demain","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/depistage-des-nitrosamines-elargissez-le-champ-dinvestigation-aujourdhui-reduisez-les-couts-demain\/","title":{"rendered":"D\u00e9pistage des nitrosamines&nbsp;: \u00e9largissez le champ d\u2019investigation aujourd\u2019hui, r\u00e9duisez les co\u00fbts demain"},"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\" style=\"--awb-text-transform:none;\"><h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 17; line-height: 1.67; --minfontsize: 17;\" data-fontsize=\"17\" data-lineheight=\"28.39px\"><span style=\"font-size: 14pt;\"><strong>Introduction<\/strong><\/span><\/h3>\n<div class=\"blog-content\">\n<div class=\"field field-name-body field-type-text-with-summary field-label-hidden\">\n<div class=\"field-items\">\n<div class=\"field-item even\">\n<p><span style=\"font-size: 14pt;\">Notre responsable du contr\u00f4le qualit\u00e9 et cofondateur de Pharmaprogress, le Dr Luca Gramaccioni, poss\u00e8de pr\u00e8s de vingt ans d&rsquo;exp\u00e9rience en spectrom\u00e9trie de masse. Il nous parle ici du r\u00e9cent report de l&rsquo;\u00e9ch\u00e9ance concernant les nitrosamines et de nos analyses de pointe. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Les autorit\u00e9s r\u00e9glementaires ont r\u00e9cemment prolong\u00e9 jusqu&rsquo;au 1er octobre 2020 le d\u00e9lai d&rsquo;\u00e9valuation des risques li\u00e9s aux nitrosamines, offrant ainsi \u00e0 nos clients un d\u00e9lai suppl\u00e9mentaire pour r\u00e9aliser des analyses pr\u00e9liminaires plus pouss\u00e9es et minimiser les co\u00fbts li\u00e9s au dosage des nitrosamines apr\u00e8s l&rsquo;\u00e9valuation des risques. Nos \u00e9quipes KYMOS et PHARMAPROGRESS travaillent sans rel\u00e2che pour adapter nos services de pointe en mati\u00e8re de nitrosamines aux nouvelles exigences. Nos deux m\u00e9thodes analytiques alternatives (HS-GC\/MS et LC-MS\/MS) et notre liste valid\u00e9e de 15 nitrosamines sont d\u00e9sormais enrichies de tests de d\u00e9pistage des nitrosamines non conformes aux BPF, plus rapides, plus flexibles et plus \u00e9conomiques. Ces tests sont destin\u00e9s aux entreprises souhaitant obtenir des donn\u00e9es suppl\u00e9mentaires sur leurs produits, excipients ou mati\u00e8res premi\u00e8res afin de r\u00e9aliser une \u00e9valuation des risques plus robuste et d&rsquo;\u00e9viter des \u00e9tapes de dosage suppl\u00e9mentaires. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Un d\u00e9pistage rapide des nitrosamines peut pr\u00e9senter de nombreux avantages lorsque&nbsp;:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">L&rsquo;analyse des risques n&rsquo;est pas termin\u00e9e.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Les fournisseurs n&rsquo;ont pas fourni toutes les r\u00e9ponses dont votre entreprise a besoin.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Les entreprises doivent consolider les r\u00e9sultats de l&rsquo;\u00e9valuation des risques.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Profiter des 6 mois suppl\u00e9mentaires disponibles pour produire la documentation.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Le criblage rapide bas\u00e9 sur la technique HS-GC\/MS est une excellente opportunit\u00e9 pour analyser rapidement les mati\u00e8res premi\u00e8res afin d&rsquo;\u00e9tudier en profondeur leur teneur en nitrosamines.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Points forts de notre m\u00e9thode HS-GC\/MS<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">Haute sensibilit\u00e9 (ci-apr\u00e8s deux alternatives pour le chromatogramme \u00e0 0,03 ppm).<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: 14pt;\">D\u00e9termination simultan\u00e9e des 10 nitrosamines les plus volatiles, y compris celles mentionn\u00e9es \u00e0 la fois par l&rsquo;EMA\/FDA et l&rsquo;USP&lt; 381&gt; (compos\u00e9s impurs nitrosaminiques dans les \u00e9lastom\u00e8res pour syst\u00e8mes d&#8217;emballage\/d&rsquo;administration d&rsquo;injections).<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: 14pt;\">L&rsquo;\u00e9chantillonnage automatique de l&rsquo;espace de t\u00eate permet de s&rsquo;affranchir des difficult\u00e9s li\u00e9es \u00e0 la solubilisation des mati\u00e8res premi\u00e8res. Il est ainsi possible de traiter diff\u00e9rents mat\u00e9riaux rapidement. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Limite de d\u00e9tection tr\u00e8s robuste et reproductible \u00e0 1 ppb.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\"><strong>Points forts de notre m\u00e9thode LC-MS\/MS<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">La m\u00e9thode LC-MS\/MS avec source d&rsquo;ions APCI peut \u00eatre utilis\u00e9e dans les sc\u00e9narios et situations suivants&nbsp;:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">Nitrosamines volatiles et non volatiles simultan\u00e9ment<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">  Haute sensibilit\u00e9 gr\u00e2ce \u00e0 la s\u00e9lectivit\u00e9 garantie par le triple quadrip\u00f4le<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Diff\u00e9rentes conditions permettent de personnaliser la m\u00e9thode, autorisant ainsi une s\u00e9lectivit\u00e9 variable pour les nitrosamines d&rsquo;int\u00e9r\u00eat et les autres composants des produits.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Phase stationnaire C18<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">phase stationnaire CN<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Phase stationnaire du PFP<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Phase stationnaire ph\u00e9nyl hexyle (ci-apr\u00e8s chromatogrammes \u00e0 0,03 ppm)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Chromatogrammes pour les nitrosamines suppl\u00e9mentaires&nbsp;:<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">L&rsquo;EMA a prolong\u00e9 <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/post-authorisation\/pharmacovigilance-post-authorisation\/referral-procedures-human-medicines\/nitrosamine-impurities\" target=\"_blank\" rel=\"noopener\" data-wpel-link=\"external\">le d\u00e9lai<\/a> pour achever la premi\u00e8re \u00e9tape de l&rsquo;examen des proc\u00e9d\u00e9s de fabrication.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Cliquez ici pour en savoir plus sur nos <a href=\"https:\/\/kymos.com\/fr\/services\/analyse-cmc-et-controle-qualite\/elements-nitrosamines-et-autres-impuretes\/\" data-wpel-link=\"internal\">capacit\u00e9s de d\u00e9pistage des nitrosamines<\/a> ou contactez-nous \u00e0 l&rsquo; <a href=\"mailto:info@kymos.com\" data-wpel-link=\"internal\">adresse commercial@kymos.com<\/a> <a href=\"mailto:commercial@kymos.com?subject=Nouveaux%20instruments%20chez%20Kymos\" data-wpel-link=\"internal\">.<\/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":7,"featured_media":27311,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[267],"tags":[],"class_list":["post-27309","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>D\u00e9pistage des nitrosamines | Groupe Kymos<\/title>\n<meta name=\"description\" content=\"Apprenez-en davantage sur la derni\u00e8re prolongation du d\u00e9lai concernant les nitrosamines et sur nos d\u00e9pistages de pointe r\u00e9alis\u00e9s par le Dr Luca Gramaccioni.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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