{"id":217046,"date":"2025-07-01T08:54:46","date_gmt":"2025-07-01T07:54:46","guid":{"rendered":"https:\/\/www.merieuxnutrisciences.com\/servicios-farmaceuticos\/nitrosamines-identification\/"},"modified":"2025-09-29T12:44:09","modified_gmt":"2025-09-29T11:44:09","slug":"identificacion-de-nitrosaminas","status":"publish","type":"page","link":"https:\/\/www.merieuxnutrisciences.com\/es\/servicios-farmaceuticos\/identificacion-de-nitrosaminas\/","title":{"rendered":"Identificaci\u00f3n de Nitrosaminas para Productos Farmac\u00e9uticos"},"content":{"rendered":"\n<div class=\"page-header-block-wrapper fullwidth-block\">\n    <div class=\"acf-page-header\" style=\"background-image: url('https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/servizi-correlati_Nitrosammine-1.jpg'); \">\n        <div class=\"overlay\"><\/div>\n        <div class=\"acf-page-header-container\">\n                            <div class=\"image-wrapper\">\n                    <img decoding=\"async\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/nitrosamine.png\" alt=\"Icon\" \/>\n                <\/div>\n                        <h1>Identificaci\u00f3n de Nitrosaminas para Productos Farmac\u00e9uticos<\/h1>\n        <\/div>\n    <\/div>\n<\/div>\n\n<style>\n.page-header-block-wrapper{\n    margin-bottom: 60px;\n}\n\n.fullwidth-block {\n    max-width: none !important;\n    width: 100vw !important;\n    position: relative;\n    padding:0px;\n    left: 50%;\n    right: 50%;\n    margin-left: -50vw;\n    margin-right: -50vw;\n}\n\n.acf-page-header {\n    background-size: cover;\n    background-position: center;\n    display: flex;\n    position: relative;\n    min-height: 250px; \n}\n\n.acf-page-header-container{\n    margin: 0 auto;\n    padding: 48px 24px;\n    display: flex;\n    flex-direction: column;\n    justify-content: end;\n    align-items: center;\n}\n\n.acf-page-header .overlay {\n    position: absolute;\n    top: 0;\n    left: 0;\n    right: 0;\n    bottom: 0;\n    background: linear-gradient(to top, var(--global-palette4), transparent);\n    z-index: 1;\n}\n\n.acf-page-header-container .image-wrapper{\n    position:relative;\n    height: 70px;\n    width: 70px;\n    background: var(--global-palette4);\n    border-radius: 50%;\n    z-index: 1;\n}\n\n.acf-page-header-container img{\n    position: absolute;\n    top: 50%;\n    left: 50%;\n    transform: translate(-50%, -50%);\n    max-width:40px;\n    z-index: 2;\n}\n\n.acf-page-header h1 {\n    display:block;\n    position: relative;\n    z-index: 2;\n    color:white;\n    text-align: center;\n}\n\n@media (min-width: 1025px) {\n    .acf-page-header-container{\n        width: 1290px;\n    }\n    \n}\n\n@media (max-width: 1024px) {\n    .acf-page-header-container {\n        align-self: end;\n    }\n    .acf-page-header .overlay {\n        background: linear-gradient(to top, var(--global-palette4), transparent);\n    }\n}\n\n@media (max-width: 768px) {\n    .acf-page-header .overlay {\n        background: linear-gradient(to top, var(--global-palette4), transparent);\n    }\n    .acf-page-header h1 {\n        font-size:28px;\n    }\n}\n\n<\/style>\n\n\n\n\n<h2 class=\"wp-block-heading\">Identificaci\u00f3n de Nitrosaminas para Productos Farmac\u00e9uticos: Nuestro Laboratorio<\/h2>\n\n\n\n<p>El laboratorio <strong>M\u00e9rieux NutriSciences | Pharma &amp; Healthcare<\/strong>, dedicado al an\u00e1lisis de nitrosaminas, es un centro de excelencia que combina tecnolog\u00edas cient\u00edficas avanzadas y conocimientos especializados para garantizar la seguridad de los productos farmac\u00e9uticos. Este laboratorio cuenta con una amplia gama de instrumentaci\u00f3n de vanguardia y con recursos humanos altamente cualificados.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-structure-and-capabilities-of-the-laboratory\">Estructura y Capacidades de nuestro Laboratorio<\/h3>\n\n\n        <div class=\"wp-block-accordion\">\n            \n                                    <div class=\"nq-c-Dropdown\" data-nqis=\"Dropdown\">\n                        <div data-nqdisplay=\"small\"><\/div>\n                        <div data-nqdisplay=\"large\"><\/div>\n    \n                        <div class=\"nq-c-Dropdown-toggler nq-c-Heading nq-u-blue\" data-lvl=\"3\" aria-expanded=\"false\">\n                            <span class=\"nq-c-Dropdown-toggler-txt\">Experiencia y Conocimientos<\/span>\n                            <span class=\"nq-c-Dropdown-toggler-icon\">\n                                \n                                <span class=\"icon-minus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20.000000pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M936 2697 c-109 -61 -106 -221 5 -277 38 -20 66 -20 1619 -20 1553 0\n1581 0 1619 20 113 57 113 223 0 280 -38 20 -66 20 -1621 20 l-1583 0 -39 -23z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                <span class=\"icon-plus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M2480 4288 c-18 -13 -43 -36 -54 -51 -21 -28 -21 -35 -24 -773 l-2\n-744 -744 -2 c-738 -3 -745 -3 -773 -24 -98 -73 -98 -195 0 -268 28 -21 35\n-21 773 -24 l744 -2 2 -744 c3 -738 3 -745 24 -773 73 -98 195 -98 268 0 21\n28 21 35 24 773 l2 744 744 2 c738 3 745 3 773 24 98 73 98 195 0 268 -28 21\n-35 21 -773 24 l-744 2 -2 744 c-3 738 -3 745 -24 773 -35 48 -82 73 -134 73\n-32 0 -57 -7 -80 -22z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                \n                            <\/span>\n                        <\/div>\n                        <div class=\"nq-c-Dropdown-menu\" hidden>\n                                                            <ul>\n<li style=\"font-size: 18px;\"><strong>M\u00e1s de 15 a\u00f1os de experiencia <\/strong>en el an\u00e1lisis y estudio de nitrosaminas en distintos sectores.<\/li>\n<li style=\"font-size: 18px;\"><strong>M\u00e1s de 25 especialistas <\/strong>dedicados exclusivamente al estudio de nitrosaminas, con experiencia espec\u00edfica y avanzada en este campo.<\/li>\n<li style=\"font-size: 18px;\"><strong>Desarrollo de m\u00e1s de 70 m\u00e9todos para el an\u00e1lisis de NDSRIs<\/strong> (impurezas relacionadas con sustancias activas derivadas de nitrosaminas).<\/li>\n<\/ul>\n    \n                                                                                    <\/div>\n                    <\/div>\n                            \n                                    <div class=\"nq-c-Dropdown\" data-nqis=\"Dropdown\">\n                        <div data-nqdisplay=\"small\"><\/div>\n                        <div data-nqdisplay=\"large\"><\/div>\n    \n                        <div class=\"nq-c-Dropdown-toggler nq-c-Heading nq-u-blue\" data-lvl=\"3\" aria-expanded=\"false\">\n                            <span class=\"nq-c-Dropdown-toggler-txt\">Tecnolog\u00edas y Equipos<\/span>\n                            <span class=\"nq-c-Dropdown-toggler-icon\">\n                                \n                                <span class=\"icon-minus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20.000000pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M936 2697 c-109 -61 -106 -221 5 -277 38 -20 66 -20 1619 -20 1553 0\n1581 0 1619 20 113 57 113 223 0 280 -38 20 -66 20 -1621 20 l-1583 0 -39 -23z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                <span class=\"icon-plus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M2480 4288 c-18 -13 -43 -36 -54 -51 -21 -28 -21 -35 -24 -773 l-2\n-744 -744 -2 c-738 -3 -745 -3 -773 -24 -98 -73 -98 -195 0 -268 28 -21 35\n-21 773 -24 l744 -2 2 -744 c3 -738 3 -745 24 -773 73 -98 195 -98 268 0 21\n28 21 35 24 773 l2 744 744 2 c738 3 745 3 773 24 98 73 98 195 0 268 -28 21\n-35 21 -773 24 l-744 2 -2 744 c-3 738 -3 745 -24 773 -35 48 -82 73 -134 73\n-32 0 -57 -7 -80 -22z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                \n                            <\/span>\n                        <\/div>\n                        <div class=\"nq-c-Dropdown-menu\" hidden>\n                                                            <ul>\n<li style=\"font-size: 18px;\"><strong>M\u00e1s de 6 t\u00e9cnicas anal\u00edticas diferentes<\/strong>, incluyendo MS\/MS y HRMS acopladas a sistemas GC y LC, esenciales para detectar incluso las trazas m\u00e1s peque\u00f1as de nitrosaminas en los productos.<\/li>\n<li style=\"font-size: 18px;\"><strong>Equipados con 7 sistemas<\/strong> <strong data-start=\"1336\" data-end=\"1348\">LC\/MS-MS<\/strong> dedicados exclusivamente al an\u00e1lisis de nitrosaminas.<\/li>\n<li style=\"font-size: 18px;\">Realizaci\u00f3n de m\u00e1s de 15.000 ensayos de nitrosaminas en productos farmac\u00e9uticos y principios activos (APIs).<\/li>\n<\/ul>\n    \n                                                                                    <\/div>\n                    <\/div>\n                            \n                                    <div class=\"nq-c-Dropdown\" data-nqis=\"Dropdown\">\n                        <div data-nqdisplay=\"small\"><\/div>\n                        <div data-nqdisplay=\"large\"><\/div>\n    \n                        <div class=\"nq-c-Dropdown-toggler nq-c-Heading nq-u-blue\" data-lvl=\"3\" aria-expanded=\"false\">\n                            <span class=\"nq-c-Dropdown-toggler-txt\">Infraestructura y Entorno<\/span>\n                            <span class=\"nq-c-Dropdown-toggler-icon\">\n                                \n                                <span class=\"icon-minus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20.000000pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M936 2697 c-109 -61 -106 -221 5 -277 38 -20 66 -20 1619 -20 1553 0\n1581 0 1619 20 113 57 113 223 0 280 -38 20 -66 20 -1621 20 l-1583 0 -39 -23z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                <span class=\"icon-plus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M2480 4288 c-18 -13 -43 -36 -54 -51 -21 -28 -21 -35 -24 -773 l-2\n-744 -744 -2 c-738 -3 -745 -3 -773 -24 -98 -73 -98 -195 0 -268 28 -21 35\n-21 773 -24 l744 -2 2 -744 c3 -738 3 -745 24 -773 73 -98 195 -98 268 0 21\n28 21 35 24 773 l2 744 744 2 c738 3 745 3 773 24 98 73 98 195 0 268 -28 21\n-35 21 -773 24 l-744 2 -2 744 c-3 738 -3 745 -24 773 -35 48 -82 73 -134 73\n-32 0 -57 -7 -80 -22z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                \n                            <\/span>\n                        <\/div>\n                        <div class=\"nq-c-Dropdown-menu\" hidden>\n                                                            <ul>\n<li style=\"font-size: 18px;\">El laboratorio est\u00e1 ubicado en unas instalaciones modernas con 3 departamentos distintos, cada uno dedicado a \u00e1reas espec\u00edficas de investigaci\u00f3n y an\u00e1lisis.<\/li>\n<li style=\"font-size: 18px;\">El entorno de trabajo est\u00e1 dise\u00f1ado para fomentar la colaboraci\u00f3n multidisciplinar entre distintos equipos especializados, garantizando un enfoque integrado y completo en el an\u00e1lisis de nitrosaminas.<\/li>\n<\/ul>\n    \n                                                                                    <\/div>\n                    <\/div>\n                                    <\/div>\n    \n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"2880\" height=\"986\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/shutterstock_2130175733-NI-LAB_ENG-OK-01-scaled.jpg\" alt=\"\" class=\"wp-image-177299\" style=\"object-fit:cover\" srcset=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/shutterstock_2130175733-NI-LAB_ENG-OK-01-scaled.jpg 2880w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/shutterstock_2130175733-NI-LAB_ENG-OK-01-300x103.jpg 300w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/shutterstock_2130175733-NI-LAB_ENG-OK-01-1024x351.jpg 1024w, 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xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" fill=\"none\" viewBox=\"0 0 12 12\">\n\t\t\t\t<path fill=\"#fff\" d=\"M2 0a2 2 0 0 0-2 2v2h1.5V2a.5.5 0 0 1 .5-.5h2V0H2Zm2 10.5H2a.5.5 0 0 1-.5-.5V8H0v2a2 2 0 0 0 2 2h2v-1.5ZM8 12v-1.5h2a.5.5 0 0 0 .5-.5V8H12v2a2 2 0 0 1-2 2H8Zm2-12a2 2 0 0 1 2 2v2h-1.5V2a.5.5 0 0 0-.5-.5H8V0h2Z\" \/>\n\t\t\t<\/svg>\n\t\t<\/button><\/figure>\n<\/div>\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Nuestros Expertos<\/strong><\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">        <div class=\"wp-block-accordion\">\n            \n                                    <div class=\"nq-c-Dropdown\" data-nqis=\"Dropdown\">\n                        <div data-nqdisplay=\"small\"><\/div>\n                        <div data-nqdisplay=\"large\"><\/div>\n    \n                        <div class=\"nq-c-Dropdown-toggler nq-c-Heading nq-u-blue\" data-lvl=\"3\" aria-expanded=\"false\">\n                            <span class=\"nq-c-Dropdown-toggler-txt\">Emiliano DE DOMINICIS \u2013 Director de Investigaci\u00f3n en Qu\u00edmica<\/span>\n                            <span class=\"nq-c-Dropdown-toggler-icon\">\n                                \n                                <span class=\"icon-minus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20.000000pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M936 2697 c-109 -61 -106 -221 5 -277 38 -20 66 -20 1619 -20 1553 0\n1581 0 1619 20 113 57 113 223 0 280 -38 20 -66 20 -1621 20 l-1583 0 -39 -23z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                <span class=\"icon-plus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M2480 4288 c-18 -13 -43 -36 -54 -51 -21 -28 -21 -35 -24 -773 l-2\n-744 -744 -2 c-738 -3 -745 -3 -773 -24 -98 -73 -98 -195 0 -268 28 -21 35\n-21 773 -24 l744 -2 2 -744 c3 -738 3 -745 24 -773 73 -98 195 -98 268 0 21\n28 21 35 24 773 l2 744 744 2 c738 3 745 3 773 24 98 73 98 195 0 268 -28 21\n-35 21 -773 24 l-744 2 -2 744 c-3 738 -3 745 -24 773 -35 48 -82 73 -134 73\n-32 0 -57 -7 -80 -22z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                \n                            <\/span>\n                        <\/div>\n                        <div class=\"nq-c-Dropdown-menu\" hidden>\n                                                            <p><strong>Trayectoria<br \/>\n<\/strong>M\u00e1s de 20 a\u00f1os de experiencia industrial y acad\u00e9mica en distintos \u00e1mbitos de la seguridad alimentaria y farmac\u00e9utica.<\/p>\n<p><strong>Rol<br \/>\n<\/strong>Dirige un equipo de m\u00e1s de 20 personas dedicadas a I+D en Qu\u00edmica Anal\u00edtica (con especializaci\u00f3n en espectrometr\u00eda de masas). Actualmente es Director de Investigaci\u00f3n en Qu\u00edmica \u2013 Project Manager en M\u00e9rieux NutriSciences. Participa activamente en proyectos cient\u00edficos financiados, congresos cient\u00edficos (presentaciones y p\u00f3sters) y en la publicaci\u00f3n de art\u00edculos en revistas cient\u00edficas en diversas \u00e1reas de aplicaci\u00f3n.<\/p>\n    \n                                                                                    <\/div>\n                    <\/div>\n                            \n                                    <div class=\"nq-c-Dropdown\" data-nqis=\"Dropdown\">\n                        <div data-nqdisplay=\"small\"><\/div>\n                        <div data-nqdisplay=\"large\"><\/div>\n    \n                        <div class=\"nq-c-Dropdown-toggler nq-c-Heading nq-u-blue\" data-lvl=\"3\" aria-expanded=\"false\">\n                            <span class=\"nq-c-Dropdown-toggler-txt\">Laura ZAMPIERI \u2013 Responsable de Proyectos Especiales de Qu\u00edmica<\/span>\n                            <span class=\"nq-c-Dropdown-toggler-icon\">\n                                \n                                <span class=\"icon-minus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20.000000pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M936 2697 c-109 -61 -106 -221 5 -277 38 -20 66 -20 1619 -20 1553 0\n1581 0 1619 20 113 57 113 223 0 280 -38 20 -66 20 -1621 20 l-1583 0 -39 -23z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                <span class=\"icon-plus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M2480 4288 c-18 -13 -43 -36 -54 -51 -21 -28 -21 -35 -24 -773 l-2\n-744 -744 -2 c-738 -3 -745 -3 -773 -24 -98 -73 -98 -195 0 -268 28 -21 35\n-21 773 -24 l744 -2 2 -744 c3 -738 3 -745 24 -773 73 -98 195 -98 268 0 21\n28 21 35 24 773 l2 744 744 2 c738 3 745 3 773 24 98 73 98 195 0 268 -28 21\n-35 21 -773 24 l-744 2 -2 744 c-3 738 -3 745 -24 773 -35 48 -82 73 -134 73\n-32 0 -57 -7 -80 -22z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                \n                            <\/span>\n                        <\/div>\n                        <div class=\"nq-c-Dropdown-menu\" hidden>\n                                                            <p><strong>Trayectoria<br \/>\n<\/strong>M\u00e1s de 15 a\u00f1os de experiencia en distintos campos, incluyendo 13 a\u00f1os de experiencia en instalaciones GMP.<\/p>\n<p><strong>Rol<br \/>\n<\/strong>Responsable en el equipo de Validaci\u00f3n GMP, implicada en la validaci\u00f3n de m\u00e9todos conforme a gu\u00edas ICH u otras normativas internacionales, en cumplimiento con est\u00e1ndares cGMP\/euGMP o GLP.<\/p>\n    \n                                                                                    <\/div>\n                    <\/div>\n                                    <\/div>\n    <\/div>\n<\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Nuestros Servicios<\/h2>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-confirmatory-testing-method-development-amp-validation\">Ensayos confirmatorios \u2013 Desarrollo y validaci\u00f3n de m\u00e9todos<\/h3>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-multiresidual-analysis-small-nitrosamines\">An\u00e1lisis multirresidual (peque\u00f1as nitrosaminas)<\/h4>\n\n\n<div class=\"wp-block-image\">\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;6a0e54d515247&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"6a0e54d515247\" class=\"aligncenter size-full wp-lightbox-container\"><img loading=\"lazy\" decoding=\"async\" width=\"2880\" height=\"516\" data-wp-class--hide=\"state.isContentHidden\" data-wp-class--show=\"state.isContentVisible\" data-wp-init=\"callbacks.setButtonStyles\" data-wp-on--click=\"actions.showLightbox\" data-wp-on--load=\"callbacks.setButtonStyles\" data-wp-on-window--resize=\"callbacks.setButtonStyles\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-15_Tavola-disegno-1-scaled.jpg\" alt=\"\" class=\"wp-image-177263\" style=\"object-fit:cover\" srcset=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-15_Tavola-disegno-1-scaled.jpg 2880w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-15_Tavola-disegno-1-300x54.jpg 300w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-15_Tavola-disegno-1-1024x184.jpg 1024w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-15_Tavola-disegno-1-768x138.jpg 768w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-15_Tavola-disegno-1-1536x275.jpg 1536w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-15_Tavola-disegno-1-2048x367.jpg 2048w\" sizes=\"auto, (max-width: 2880px) 100vw, 2880px\" \/><button\n\t\t\tclass=\"lightbox-trigger\"\n\t\t\ttype=\"button\"\n\t\t\taria-haspopup=\"dialog\"\n\t\t\taria-label=\"Agrandar\"\n\t\t\tdata-wp-init=\"callbacks.initTriggerButton\"\n\t\t\tdata-wp-on--click=\"actions.showLightbox\"\n\t\t\tdata-wp-style--right=\"state.imageButtonRight\"\n\t\t\tdata-wp-style--top=\"state.imageButtonTop\"\n\t\t>\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" fill=\"none\" viewBox=\"0 0 12 12\">\n\t\t\t\t<path fill=\"#fff\" d=\"M2 0a2 2 0 0 0-2 2v2h1.5V2a.5.5 0 0 1 .5-.5h2V0H2Zm2 10.5H2a.5.5 0 0 1-.5-.5V8H0v2a2 2 0 0 0 2 2h2v-1.5ZM8 12v-1.5h2a.5.5 0 0 0 .5-.5V8H12v2a2 2 0 0 1-2 2H8Zm2-12a2 2 0 0 1 2 2v2h-1.5V2a.5.5 0 0 0-.5-.5H8V0h2Z\" \/>\n\t\t\t<\/svg>\n\t\t<\/button><\/figure>\n<\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-target-methods-more-than-70-methods-for-specific-ndsris-or-no-impurities-available-not-exhaustive-list\">M\u00e9todos dirigidos (m\u00e1s de 70 m\u00e9todos disponibles para NDSRIs o impurezas relacionadas con nitrosaminas) \u2013 <em>Lista no exhaustiva<\/em><\/h4>\n\n\n<div class=\"wp-block-image\">\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;6a0e54d515a8e&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"6a0e54d515a8e\" class=\"aligncenter size-full wp-lightbox-container\"><img loading=\"lazy\" decoding=\"async\" width=\"2880\" height=\"1434\" data-wp-class--hide=\"state.isContentHidden\" data-wp-class--show=\"state.isContentVisible\" data-wp-init=\"callbacks.setButtonStyles\" data-wp-on--click=\"actions.showLightbox\" data-wp-on--load=\"callbacks.setButtonStyles\" data-wp-on-window--resize=\"callbacks.setButtonStyles\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-70_Tavola-disegno-1-scaled.jpg\" alt=\"\" class=\"wp-image-177245\" style=\"object-fit:cover\" srcset=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-70_Tavola-disegno-1-scaled.jpg 2880w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-70_Tavola-disegno-1-300x149.jpg 300w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-70_Tavola-disegno-1-1024x510.jpg 1024w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-70_Tavola-disegno-1-768x382.jpg 768w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-70_Tavola-disegno-1-1536x765.jpg 1536w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-70_Tavola-disegno-1-2048x1020.jpg 2048w\" sizes=\"auto, (max-width: 2880px) 100vw, 2880px\" \/><button\n\t\t\tclass=\"lightbox-trigger\"\n\t\t\ttype=\"button\"\n\t\t\taria-haspopup=\"dialog\"\n\t\t\taria-label=\"Agrandar\"\n\t\t\tdata-wp-init=\"callbacks.initTriggerButton\"\n\t\t\tdata-wp-on--click=\"actions.showLightbox\"\n\t\t\tdata-wp-style--right=\"state.imageButtonRight\"\n\t\t\tdata-wp-style--top=\"state.imageButtonTop\"\n\t\t>\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" fill=\"none\" viewBox=\"0 0 12 12\">\n\t\t\t\t<path fill=\"#fff\" d=\"M2 0a2 2 0 0 0-2 2v2h1.5V2a.5.5 0 0 1 .5-.5h2V0H2Zm2 10.5H2a.5.5 0 0 1-.5-.5V8H0v2a2 2 0 0 0 2 2h2v-1.5ZM8 12v-1.5h2a.5.5 0 0 0 .5-.5V8H12v2a2 2 0 0 1-2 2H8Zm2-12a2 2 0 0 1 2 2v2h-1.5V2a.5.5 0 0 0-.5-.5H8V0h2Z\" \/>\n\t\t\t<\/svg>\n\t\t<\/button><\/figure>\n<\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-screening-target\">Screening dirigido<\/h4>\n\n\n\n<p>Screening mediante HRMS y\/o MS\/HRMS (bitrosaminas sin est\u00e1ndares de referencia disponibles).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-nap-test\"><strong>Test<\/strong> <strong>NAP<\/strong><\/h4>\n\n\n\n<p>Ensayo cualitativo residual \/ an\u00e1lisis de trazas para verificar la formaci\u00f3n potencial de nitrosaminas espec\u00edficas en un entorno nitrosante, mediante: LC-MS\/MS y\/o HRMS y\/o MS\/HRMS y\/o UV.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"2880\" height=\"1415\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/mxns_NAP-TEST_eng-rev_Tavola-disegno-1-scaled.jpg\" alt=\"\" class=\"wp-image-177227\" style=\"object-fit:cover\" srcset=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/mxns_NAP-TEST_eng-rev_Tavola-disegno-1-scaled.jpg 2880w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/mxns_NAP-TEST_eng-rev_Tavola-disegno-1-300x147.jpg 300w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/mxns_NAP-TEST_eng-rev_Tavola-disegno-1-1024x503.jpg 1024w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/mxns_NAP-TEST_eng-rev_Tavola-disegno-1-768x377.jpg 768w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/mxns_NAP-TEST_eng-rev_Tavola-disegno-1-1536x755.jpg 1536w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/mxns_NAP-TEST_eng-rev_Tavola-disegno-1-2048x1006.jpg 2048w\" sizes=\"auto, (max-width: 2880px) 100vw, 2880px\" \/><\/figure>\n<\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>En 2024, la <strong>EFPIA <\/strong>(Federaci\u00f3n Europea de Industrias y Asociaciones Farmac\u00e9uticas) public\u00f3 el documento \u201c<a href=\"https:\/\/www.efpia.eu\/media\/tkbnsicy\/efpia-nitrosamines-risk-management-workflows-jun-24-udpate.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Drug Substance Workflow for Quality Risk Management of Nitrosamine Risks in Medicines<\/a>\u201d, que describe un nuevo enfoque para el test NAP. Este representa las condiciones \u00f3ptimas de preparaci\u00f3n para la formaci\u00f3n de nitrosaminas que deben examinarse. Esta gu\u00eda es esencial para determinar si pueden formarse nitrosaminas bajo las condiciones espec\u00edficas de fabricaci\u00f3n y almacenamiento de principios activos y medicamentos, informando as\u00ed las evaluaciones de riesgo y las estrategias de control.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-risk-evaluation\">Evaluaci\u00f3n de Riesgo<\/h4>\n\n\n\n<p>Ensayos de screening bajo GMP o no-GMP en materias primas de medicamentos, apoyando el proceso de evaluaci\u00f3n de riesgos en caso de ausencia de informaci\u00f3n: an\u00e1lisis multirresidual de NI y an\u00e1lisis individual de NI (con o sin est\u00e1ndar de referencia).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-new-marketing-authorisation-and-batch-release\">Nuevas Autorizaciones de Comercializaci\u00f3n y Liberaci\u00f3n de Lotes<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ensayos cuantitativos GMP de screening para demostrar la ausencia de NI antes de solicitar una nueva MA (autorizaci\u00f3n de comercializaci\u00f3n).<\/li>\n\n\n\n<li>Ensayos QC GMP para la liberaci\u00f3n anal\u00edtica de lotes.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-alerts-management\">Gesti\u00f3n de Alertas<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Desarrollo y validaci\u00f3n de m\u00e9todos dirigidos (servicio urgente).<\/li>\n\n\n\n<li>Ensayos cuantitativos GMP en APIs y medicamentos en el mercado.<\/li>\n<\/ul>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Referencias Regulatorias<\/h2>\n\n\n        <div class=\"wp-block-accordion\">\n            \n                                    <div class=\"nq-c-Dropdown\" data-nqis=\"Dropdown\">\n                        <div data-nqdisplay=\"small\"><\/div>\n                        <div data-nqdisplay=\"large\"><\/div>\n    \n                        <div class=\"nq-c-Dropdown-toggler nq-c-Heading nq-u-blue\" data-lvl=\"3\" aria-expanded=\"false\">\n                            <span class=\"nq-c-Dropdown-toggler-txt\">\u00bfQu\u00e9 son las nitrosaminas?<\/span>\n                            <span class=\"nq-c-Dropdown-toggler-icon\">\n                                \n                                <span class=\"icon-minus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20.000000pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M936 2697 c-109 -61 -106 -221 5 -277 38 -20 66 -20 1619 -20 1553 0\n1581 0 1619 20 113 57 113 223 0 280 -38 20 -66 20 -1621 20 l-1583 0 -39 -23z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                <span class=\"icon-plus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M2480 4288 c-18 -13 -43 -36 -54 -51 -21 -28 -21 -35 -24 -773 l-2\n-744 -744 -2 c-738 -3 -745 -3 -773 -24 -98 -73 -98 -195 0 -268 28 -21 35\n-21 773 -24 l744 -2 2 -744 c3 -738 3 -745 24 -773 73 -98 195 -98 268 0 21\n28 21 35 24 773 l2 744 744 2 c738 3 745 3 773 24 98 73 98 195 0 268 -28 21\n-35 21 -773 24 l-744 2 -2 744 c-3 738 -3 745 -24 773 -35 48 -82 73 -134 73\n-32 0 -57 -7 -80 -22z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                \n                            <\/span>\n                        <\/div>\n                        <div class=\"nq-c-Dropdown-menu\" hidden>\n                                                            <p>Las nitrosaminas est\u00e1n clasificadas como probables carcin\u00f3genos humanos, lo que significa que la exposici\u00f3n prolongada por encima de ciertos niveles puede aumentar el riesgo de c\u00e1ncer. Est\u00e1n presentes en algunos alimentos y suministros de agua potable, y cuando se han encontrado en medicamentos, el riesgo de desarrollar c\u00e1ncer ha sido bajo, aunque bajo evaluaci\u00f3n y control por parte de las autoridades.<\/p>\n<p>El 26 de septiembre de 2019, el <strong>CMDh<\/strong> (Heads of Medicines Agencies) public\u00f3 la nota \u201cInformation on nitrosamines for marketing authorisation holders\u201d, <strong>solicitando a todos los titulares de autorizaci\u00f3n de comercializaci\u00f3n (MAHs) de medicamentos de uso humano que contengan principios activos sintetizados qu\u00edmicamente que eval\u00faen el riesgo de presencia de impurezas de nitrosaminas en sus productos. <\/strong>A finales de 2023, tras 3 a\u00f1os de estudios e investigaciones, se revel\u00f3 un problema mucho m\u00e1s complejo debido a la <strong>formaci\u00f3n de nitrosaminas complejas (NDSRIs)<\/strong>, que requieren altos niveles de experiencia y tecnolog\u00eda para ser detectadas y as\u00ed garantizar la seguridad del producto.<\/p>\n    \n                                                                                    <\/div>\n                    <\/div>\n                            \n                                    <div class=\"nq-c-Dropdown\" data-nqis=\"Dropdown\">\n                        <div data-nqdisplay=\"small\"><\/div>\n                        <div data-nqdisplay=\"large\"><\/div>\n    \n                        <div class=\"nq-c-Dropdown-toggler nq-c-Heading nq-u-blue\" data-lvl=\"3\" aria-expanded=\"false\">\n                            <span class=\"nq-c-Dropdown-toggler-txt\">Proceso de Evaluaci\u00f3n de Riesgos<\/span>\n                            <span class=\"nq-c-Dropdown-toggler-icon\">\n                                \n                                <span class=\"icon-minus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20.000000pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M936 2697 c-109 -61 -106 -221 5 -277 38 -20 66 -20 1619 -20 1553 0\n1581 0 1619 20 113 57 113 223 0 280 -38 20 -66 20 -1621 20 l-1583 0 -39 -23z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                <span class=\"icon-plus-accordion\"><?xml version=\"1.0\" standalone=\"no\"?>\n<!DOCTYPE svg PUBLIC \"-\/\/W3C\/\/DTD SVG 20010904\/\/EN\"\n \"http:\/\/www.w3.org\/TR\/2001\/REC-SVG-20010904\/DTD\/svg10.dtd\">\n<svg version=\"1.0\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n width=\"20pt\" height=\"20pt\" viewBox=\"0 0 512.000000 512.000000\"\n preserveAspectRatio=\"xMidYMid meet\">\n\n<g transform=\"translate(0.000000,512.000000) scale(0.100000,-0.100000)\"\nfill=\"#000000\" stroke=\"none\">\n<path d=\"M2480 4288 c-18 -13 -43 -36 -54 -51 -21 -28 -21 -35 -24 -773 l-2\n-744 -744 -2 c-738 -3 -745 -3 -773 -24 -98 -73 -98 -195 0 -268 28 -21 35\n-21 773 -24 l744 -2 2 -744 c3 -738 3 -745 24 -773 73 -98 195 -98 268 0 21\n28 21 35 24 773 l2 744 744 2 c738 3 745 3 773 24 98 73 98 195 0 268 -28 21\n-35 21 -773 24 l-744 2 -2 744 c-3 738 -3 745 -24 773 -35 48 -82 73 -134 73\n-32 0 -57 -7 -80 -22z\"\/>\n<\/g>\n<\/svg>\n<\/span>\n                                \n                            <\/span>\n                        <\/div>\n                        <div class=\"nq-c-Dropdown-menu\" hidden>\n                                                            <p><strong>PASO 1 &#8211; EVALUACI\u00d3N DEL RIESGO.<\/strong> Los MAHs deben realizar una evaluaci\u00f3n de riesgo de sus medicamentos que contengan <strong>APIs qu\u00edmicos y biol\u00f3gicos<\/strong>, aplicando principios de gesti\u00f3n de riesgos de calidad seg\u00fan la gu\u00eda ICH Q9 y los principios de la gu\u00eda ICH M7 sobre evaluaci\u00f3n toxicol\u00f3gica y estrategia de control. Se requiere priorizar productos, y la evaluaci\u00f3n de riesgo de los productos de alto riesgo \/ alta prioridad debe realizarse de inmediato (ej. exposici\u00f3n diaria elevada y uso cr\u00f3nico). Los documentos de evaluaci\u00f3n de riesgos deben estar disponibles a petici\u00f3n.<\/p>\n<p><strong>PASO 2 &#8211; ENSAYOS CONFIRMATORIOS.<\/strong> Se deben realizar mediante m\u00e9todos validados y sensibles. Los MAHs deben informar de inmediato a las autoridades competentes si se confirma la presencia de una impureza de nitrosamina, independientemente de la cantidad detectada.<\/p>\n<p><strong>PASO 3 &#8211; CAMBIOS EN LA AUTORIZACI\u00d3N DE COMERCIALIZACI\u00d3N.<\/strong> Los MAHs deben solicitar una variaci\u00f3n a tiempo para introducir cualquier cambio necesario, como la modificaci\u00f3n del proceso de fabricaci\u00f3n o cambios en las especificaciones del producto.<!-- wp:spacer {\"height\":\"20px\"} --><\/p>\n    \n                                                                                    <\/div>\n                    <\/div>\n                                    <\/div>\n    \n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"2880\" height=\"1398\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Extractables-and-leachables_eng_Tavola-disegno-1-1-scaled.jpg\" alt=\"\" class=\"wp-image-177208\" style=\"width:600px\" srcset=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Extractables-and-leachables_eng_Tavola-disegno-1-1-scaled.jpg 2880w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Extractables-and-leachables_eng_Tavola-disegno-1-1-300x146.jpg 300w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Extractables-and-leachables_eng_Tavola-disegno-1-1-1024x497.jpg 1024w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Extractables-and-leachables_eng_Tavola-disegno-1-1-768x373.jpg 768w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Extractables-and-leachables_eng_Tavola-disegno-1-1-1536x746.jpg 1536w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Extractables-and-leachables_eng_Tavola-disegno-1-1-2048x994.jpg 2048w\" sizes=\"auto, (max-width: 2880px) 100vw, 2880px\" \/><\/figure>\n<\/div>\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center has-theme-palette-8-background-color has-background\">M\u00e1s informaci\u00f3n:<\/h2>\n\n\n\n<div class=\"wp-block-columns has-theme-palette-8-background-color has-background is-layout-flex wp-container-core-columns-is-layout-62db62f3 wp-block-columns-is-layout-flex\" style=\"padding-top:0;padding-bottom:0\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading has-text-align-center\">Cat\u00e1logo de An\u00e1lisis de Nitrosaminas<\/h3>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><a href=\"https:\/\/drive.google.com\/file\/d\/1BL9eRcySDUsNnwXj9GYkzfETycA3kX9N\/view\" target=\"_blank\" rel=\" noreferrer noopener\"><img loading=\"lazy\" decoding=\"async\" width=\"595\" height=\"841\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/mxns_Nitrosamines-analysis_BR0520_8_ENG_web.jpg\" alt=\"\" class=\"wp-image-180107\" style=\"width:auto;height:300px\" srcset=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/mxns_Nitrosamines-analysis_BR0520_8_ENG_web.jpg 595w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/mxns_Nitrosamines-analysis_BR0520_8_ENG_web-212x300.jpg 212w\" sizes=\"auto, (max-width: 595px) 100vw, 595px\" \/><\/a><\/figure>\n<\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-16018d1d wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button has-custom-width wp-block-button__width-100\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/drive.google.com\/file\/d\/1BL9eRcySDUsNnwXj9GYkzfETycA3kX9N\/view\" target=\"_blank\" rel=\"noopener\"><strong>DESCARGAR CAT\u00c1LOGO<\/strong><\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"padding-top:0;padding-bottom:0\">\n<h3 class=\"wp-block-heading has-text-align-center\">Lista completa de tecnolog\u00edas<\/h3>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><a href=\"https:\/\/drive.google.com\/file\/d\/1rK7x34Dq3QQ7gtUJfDzUx_TIg7XiSOmT\/view?usp=drive_link\" target=\"_blank\" rel=\" noreferrer noopener\"><img loading=\"lazy\" decoding=\"async\" width=\"688\" height=\"1024\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Pharma-List-Technologies-EN-688x1024.jpg\" alt=\"\" class=\"wp-image-179222\" style=\"width:auto;height:300px\" srcset=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Pharma-List-Technologies-EN-688x1024.jpg 688w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Pharma-List-Technologies-EN-202x300.jpg 202w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Pharma-List-Technologies-EN.jpg 721w\" sizes=\"auto, (max-width: 688px) 100vw, 688px\" \/><\/a><\/figure>\n<\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-16018d1d wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button has-custom-width wp-block-button__width-100\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/drive.google.com\/file\/d\/1rK7x34Dq3QQ7gtUJfDzUx_TIg7XiSOmT\/view?usp=drive_link\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>DESCARGAR LISTA COMPLETA DE TECNOLOG\u00cdAS<\/strong><\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n<\/div>\n\n\n<div class=\"page-cards-block-wrapper fullwidth-block\">   \n    <div class=\"page-cards-title-container\"> \n        <h2>Servicios relacionados<\/h2>    \n    <\/div>\n    <div class=\"full-width-row-page-cards-wrapper\">\n        <div class=\"page-cards-container\">\n                                            <a href=\"https:\/\/www.merieuxnutrisciences.com\/es\/servicios-farmaceuticos\/calidad-de-productos-farmaceuticos\/\" class=\"card\">\n                                            <img decoding=\"async\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/08\/Senza-titolo-2-04-1.png\" alt=\"Control de Calidad de Productos Farmac\u00e9uticos\" class=\"card-icon\"\/>\n                                        <div class=\"card-content\">\n                        <span>Control de Calidad de Productos Farmac\u00e9uticos<\/span>\n                    <\/div>\n                <\/a>\n                                            <a href=\"https:\/\/www.merieuxnutrisciences.com\/es\/servicios-farmaceuticos\/ensayos-de-impurezas\/\" class=\"card\">\n                                            <img decoding=\"async\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/08\/Analisi-delle-impurezze-blu.png\" alt=\"Ensayos de Impurezas\" class=\"card-icon\"\/>\n                                        <div class=\"card-content\">\n                        <span>Ensayos de Impurezas<\/span>\n                    <\/div>\n                <\/a>\n                                            <a href=\"https:\/\/www.merieuxnutrisciences.com\/es\/servicios-farmaceuticos\/id-y-validacion-para-la-industria-farmaceutica\/\" class=\"card\">\n                                            <img decoding=\"async\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/08\/RD-e-attivita-di-validazione-blu.png\" alt=\"I+D y Validaci\u00f3n para la Industria Farmac\u00e9utica\" class=\"card-icon\"\/>\n                                        <div class=\"card-content\">\n                        <span>I+D y Validaci\u00f3n para la Industria Farmac\u00e9utica<\/span>\n                    <\/div>\n                <\/a>\n                                <\/div>\n    <\/div>\n<\/div>    \n   \n\n<style>\n.fullwidth-block {\n    max-width: none !important;\n    width: 100vw !important;\n    position: relative;\n    padding:0px;\n    \/* left: 50%;\n    right: 50%;\n    margin-left: -50vw;\n    margin-right: -50vw; *\/\n}\n\n.page-cards-title-container{\n    max-width: 1290px;\n    margin: 100px auto 150px auto;\n    padding-left: var(--global-content-edge-padding);\n    padding-right: var(--global-content-edge-padding);\n}\n.page-cards-title-container h2{\n    color:var(--global-palette4);\n    text-align: center;\n}\n.full-width-row-page-cards-wrapper{\n    background-color: var(--global-palette4);\n}\n.page-cards-container{\n    max-width:1290px;\n    margin: 0 auto;\n    display: flex;\n    gap: 20px;\n    align-items: center;\n    justify-content: center;\n    padding: 0 12px;\n    flex-wrap: wrap;\n}\n.card {\n    display: flex;\n    transform: translate(0px, -100px);\n    flex-direction: column;\n    align-items: center;\n    justify-content: center;\n    width: 200px;\n    height: 200px;\n    background-color: white;\n    text-decoration: none;\n    color: black;\n    border: 1px solid #ccc;\n    padding: 10px;\n    box-shadow: 0 2px 5px rgba(0,0,0,0.1);\n    border-radius: 8px;\n    overflow: hidden;\n}\n\n.card-icon {\n    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