{"id":22726,"date":"2020-04-21T10:58:41","date_gmt":"2020-04-21T08:58:41","guid":{"rendered":"https:\/\/kymos.com\/news\/cribratge-de-nitrosamines-amplieu-labast-avui-reduiu-els-costos-dema\/"},"modified":"2025-08-07T09:43:13","modified_gmt":"2025-08-07T07:43:13","slug":"cribratge-de-nitrosamines-amplieu-labast-avui-reduiu-els-costos-dema","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/cribratge-de-nitrosamines-amplieu-labast-avui-reduiu-els-costos-dema\/","title":{"rendered":"Cribratge de nitrosamines: amplieu l&#8217;abast avui, redu\u00efu els costos dem\u00e0"},"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;\">Our quality control manager and co-founder of Pharmaprogress, Dr Luca Gramaccioni has nearly two decades of experience in mass spectrometry. Here, he talks about the latest Nitrosamine deadline extension and our ahead-of-the-curve screenings.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Regulatory Authorities have recently extended the Nitrosamines risk assessment deadline until October 1st 2020, giving our clients additional time to carry out more preliminary screenings and minimize the costs of Nitrosamine quantitation requirements following the risk evaluation. Our KYMOS and PHARMAPROGRESS teams constantly work to adapt our pioneering Nitrosamine services to new requirements, and thus our two alternative HS-GC\/MS and LC-MS\/MS analytical methods and validated list of 15 Nitrosamines are now being enhanced with faster, more flexible and cost-efficient non-GMP Nitrosamine screenings for those companies seeking out extra data from their products, excipients or raw materials in order to produce a more robust risk assessment and avoid additional quantification steps.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>A rapid Nitrosamine screening can bring many advantages when:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">The risk analysis is not complete.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Suppliers didn\u2019t give all the answers that your company needs.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Companies need to reinforce the results of the risk assessment.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Taking the advantage of the 6 additional months available to produce the documentation.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Rapid screening HS-GC\/MS-based is a good opportunity to quick analyze raw materials in order to deeply investigate their nitrosamines content.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Strengths of our HS-GC\/MSmethod<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">High sensitivity (hereafter two alternatives for the chromatogram at 0.03 ppm).<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: 14pt;\">Simultaneous determination of the 10 most volatile nitrosamines, including the ones mentioned both by EMA | FDA and USP &lt;381&gt; (nitrosammino impurity compounds in elastomers for packaging \/ delivery system for injections).<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: 14pt;\">The headspace autosampling allows avoiding any challenges related to the solubilization of the raw materials. This means the results present the possibility to process different materials in a short timeframe.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Very robust and reproducible LOD at 1 ppb.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\"><strong>Strengths of our LC-MS\/MS method<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">The LC-MS\/MS method with APCI ion source can be used in the following scenarios and situations:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">Volatile and not volatile nitrosamine at the same time<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"> High sensitivity because of the selectivity guaranteed by the triple quadrupole<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Different conditions to customize the method allowing different selectivity for nitrosamines of interest and the other components of the products<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">C18 stationary phase<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">CN stationary phase<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">PFP stationary phase<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Phenyl Hexyl stationary phase (hereafter chromatograms at 0.03 ppm)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Chromatograms for additional nitrosamines:<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">EMA extended <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\">the deadline<\/a> to complete step 1 of the review of manufacturing processes.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Click to discover 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\">Nitrosamine screening capabilities <\/a>or contact us on <a href=\"mailto:commercial@kymos.com?subject=New%20instruments%20at%20Kymos\" data-wpel-link=\"internal\">commercial<\/a><a href=\"mailto:info@kymos.com\" data-wpel-link=\"internal\">@kymos.com<\/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":14968,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97],"tags":[],"class_list":["post-22726","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-ca"],"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 | Kymos Group<\/title>\n<meta name=\"description\" content=\"Apr\u00e8n m\u00e9s sobre la darrera extensi\u00f3 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