{"id":23121,"date":"2020-04-21T10:58:41","date_gmt":"2020-04-21T08:58:41","guid":{"rendered":"https:\/\/kymos.com\/news\/deteccion-de-nitrosaminas-amplie-el-alcance-hoy-reduzca-los-costos-manana\/"},"modified":"2025-08-07T20:33:32","modified_gmt":"2025-08-07T18:33:32","slug":"deteccion-de-nitrosaminas-amplie-el-alcance-hoy-reduzca-los-costos-manana","status":"publish","type":"post","link":"https:\/\/kymos.com\/es\/news\/deteccion-de-nitrosaminas-amplie-el-alcance-hoy-reduzca-los-costos-manana\/","title":{"rendered":"Detecci\u00f3n de nitrosaminas: ampl\u00ede el alcance hoy, reduzca los costos ma\u00f1ana"},"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>Introducci\u00f3n<\/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;\">Nuestro director de control de calidad y cofundador de Pharmaprogress, el Dr. Luca Gramaccioni, cuenta con casi dos d\u00e9cadas de experiencia en espectrometr\u00eda de masas. En este art\u00edculo, nos habla sobre la reciente ampliaci\u00f3n del plazo para la nitrosamina y nuestros an\u00e1lisis de vanguardia. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Las autoridades reguladoras han ampliado recientemente el plazo para la evaluaci\u00f3n de riesgos de nitrosaminas hasta el 1 de octubre de 2020, lo que ofrece a nuestros clientes m\u00e1s tiempo para realizar an\u00e1lisis preliminares adicionales y minimizar los costes de cuantificaci\u00f3n de nitrosaminas tras la evaluaci\u00f3n de riesgos. Nuestros equipos de KYMOS y PHARMAPROGRESS trabajan constantemente para adaptar nuestros servicios pioneros de nitrosaminas a los nuevos requisitos. Por ello, nuestros dos m\u00e9todos anal\u00edticos alternativos HS-GC\/MS y LC-MS\/MS, as\u00ed como nuestra lista validada de 15 nitrosaminas, se est\u00e1n optimizando con an\u00e1lisis de nitrosaminas no GMP m\u00e1s r\u00e1pidos, flexibles y rentables para aquellas empresas que buscan datos adicionales de sus productos, excipientes o materias primas para generar una evaluaci\u00f3n de riesgos m\u00e1s s\u00f3lida y evitar pasos de cuantificaci\u00f3n adicionales. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Una prueba r\u00e1pida de nitrosamina puede aportar muchas ventajas cuando:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">El an\u00e1lisis de riesgos no est\u00e1 completo.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Los proveedores no dieron todas las respuestas que su empresa necesita.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Las empresas necesitan reforzar los resultados de la evaluaci\u00f3n de riesgos.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Aprovechando los 6 meses adicionales disponibles para producir la documentaci\u00f3n.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">La detecci\u00f3n r\u00e1pida basada en HS-GC\/MS es una buena oportunidad para analizar r\u00e1pidamente las materias primas con el fin de investigar en profundidad su contenido de nitrosaminas.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Puntos fuertes de nuestro m\u00e9todo HS-GC\/MS<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">Alta sensibilidad (en adelante dos alternativas para el cromatograma a 0,03 ppm).<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: 14pt;\">Determinaci\u00f3n simult\u00e1nea de las 10 nitrosaminas m\u00e1s vol\u00e1tiles, incluidas las mencionadas tanto por EMA | FDA como por USP&lt; 381&gt; (compuestos de impurezas de nitrosamino en elast\u00f3meros para sistemas de envasado\/administraci\u00f3n de inyecciones).<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: 14pt;\">El muestreo autom\u00e1tico del espacio de cabeza permite evitar cualquier problema relacionado con la solubilizaci\u00f3n de las materias primas. Esto significa que los resultados permiten procesar diferentes materiales en poco tiempo. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\">LOD muy robusto y reproducible a 1 ppb.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\"><strong>Puntos fuertes de nuestro m\u00e9todo LC-MS\/MS<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">El m\u00e9todo LC-MS\/MS con fuente de iones APCI se puede utilizar en los siguientes escenarios y situaciones:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">Nitrosamina vol\u00e1til y no vol\u00e1til al mismo tiempo<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">  Alta sensibilidad gracias a la selectividad garantizada por el triple cuadrupolo<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Diferentes condiciones para personalizar el m\u00e9todo permitiendo diferente selectividad para las nitrosaminas de inter\u00e9s y los dem\u00e1s componentes de los productos.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Fase estacionaria C18<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Fase estacionaria de CN<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Fase estacionaria de PFP<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Fase estacionaria de fenil hexilo (en adelante cromatogramas a 0,03 ppm)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Cromatogramas para nitrosaminas adicionales:<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">La EMA ampli\u00f3 <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\">el plazo<\/a> para completar el paso 1 de la revisi\u00f3n de los procesos de fabricaci\u00f3n.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Haga clic para obtener 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\">capacidades de detecci\u00f3n de nitrosaminas<\/a> <a href=\"mailto:info@kymos.com\" data-wpel-link=\"internal\">o<\/a> cont\u00e1ctenos en <a href=\"mailto:comercial@kymos.com?subject=Nuevos%20instrumentos%20en%20Kymos\" data-wpel-link=\"internal\">commercial@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":21666,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[183],"tags":[],"class_list":["post-23121","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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