{"id":203786,"date":"2025-08-13T11:37:54","date_gmt":"2025-08-13T10:37:54","guid":{"rendered":"https:\/\/www.merieuxnutrisciences.com\/?page_id=203786"},"modified":"2025-08-13T12:34:32","modified_gmt":"2025-08-13T11:34:32","slug":"identification-nitrosamines-pharmaceutiques","status":"publish","type":"page","link":"https:\/\/www.merieuxnutrisciences.com\/fr\/pharma\/identification-nitrosamines-pharmaceutiques\/","title":{"rendered":"Identification des Nitrosamines dans les Produits Pharmaceutiques"},"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>Identification des Nitrosamines dans les Produits Pharmaceutiques<\/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\">Identification des Nitrosamines dans les Produits Pharmaceutiques : Notre Laboratoire<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Notre laboratoire d\u00e9di\u00e9 \u00e0 l&rsquo;analyse des nitrosamines est un centre d&rsquo;excellence qui allie technologies scientifiques avanc\u00e9es et comp\u00e9tences pointues pour garantir la s\u00e9curit\u00e9 des produits pharmaceutiques. Ce laboratoire est dot\u00e9 d&rsquo;un large \u00e9ventail d&rsquo;\u00e9quipements de pointe et d&rsquo;\u00e9quipes hautement qualifi\u00e9es.<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-structure-and-capabilities-of-the-laboratory\">Structure et Capacit\u00e9s de Notre Laboratoire<\/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\">Exp\u00e9rience et comp\u00e9tences<\/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><span style=\"font-weight: 400;\"><strong>+15 ans d\u2019exp\u00e9rience<\/strong> dans l\u2019analyse et l\u2019\u00e9tude des nitrosamines dans divers secteurs.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>+25 sp\u00e9cialistes d\u00e9di\u00e9s exclusivement \u00e0 l&rsquo;\u00e9tude des nitrosamines<\/strong>, avec des comp\u00e9tences sp\u00e9cifiques et avanc\u00e9es dans ce secteur.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>+70 m\u00e9thodes d\u00e9velopp\u00e9es pour l&rsquo;analyse des NDSRI<\/strong> (<em>Nitrosamine drug substance-related impurities<\/em>).<\/span><\/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\">Technologies et \u00e9quipements<\/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><span style=\"font-weight: 400;\"><strong>+6 techniques analytiques diff\u00e9rentes<\/strong>, dont des spectrom\u00e8tres de masse (HRMS, MS\/MS) coupl\u00e9s \u00e0 des syst\u00e8mes chromatographiques hautes performances, indispensables pour d\u00e9tecter la moindre trace de nitrosamines dans les produits.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>\u00c9quip\u00e9 de 7 LC\/MS-MS<\/strong> d\u00e9di\u00e9s exclusivement aux tests nitrosamines.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><strong>+15 000 tests r\u00e9alis\u00e9s pour diff\u00e9rentes nitrosamines sur des produits pharmaceutiques<\/strong><\/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\">Infrastructures et environnement<\/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-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Le laboratoire est situ\u00e9 dans une<strong> structure moderne qui abrite 3 d\u00e9partements diff\u00e9rents<\/strong>, chacun d\u00e9di\u00e9 \u00e0 des domaines sp\u00e9cifiques de recherche et d&rsquo;analyse.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">L&rsquo;environnement de travail a \u00e9t\u00e9 con\u00e7u pour encourager la collaboration interdisciplinaire entre les \u00e9quipes, garantissant une approche int\u00e9gr\u00e9e et compl\u00e8te des analyses.<\/span><\/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\" 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style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-merieux-nutrisciences-pharma-amp-healthcare-s-key-milestones\">Les \u00e9tapes cl\u00e9s de M\u00e9rieux NutriSciences | Pharma &amp; Healthcare sur le sujet des Nitrosamines<\/h3>\n\n\n<div class=\"wp-block-image\">\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;6a2067fb7da46&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"6a2067fb7da46\" class=\"aligncenter size-full wp-lightbox-container\"><img loading=\"lazy\" decoding=\"async\" width=\"2880\" height=\"1472\" 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--pointerdown=\"actions.preloadImage\" data-wp-on--pointerenter=\"actions.preloadImageWithDelay\" data-wp-on--pointerleave=\"actions.cancelPreload\" 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class=\"nq-c-Dropdown-toggler-txt\">Sergio FASAN &#8211; Directeur commercial<\/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><b>Background<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Directeur Commercial de la Business Unit Pharma, Sant\u00e9 &amp; Cosm\u00e9tique de M\u00e9rieux NutriSciences Italia.<\/span><\/p>\n<p><b>R\u00f4le<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Il a commenc\u00e9 \u00e0 collaborer avec Chelab srl (aujourd&rsquo;hui M\u00e9rieux NutriSciences) il y a 25 ans, en occupant diverses fonctions au fil du temps. De responsable de laboratoire, il est devenu responsable du contr\u00f4le qualit\u00e9 du site pharmaceutique Chelab, puis Directeur du Centre de Tests BPLC et responsable de la Business Unit de la division GxP de M\u00e9rieux NutriSciences Italie.<\/span><\/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\">Emiliano DE DOMINICIS &#8211; Directeur de recherche en Chimie<\/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><b>Background<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Scientifique avec plus de 20 ans d\u2019exp\u00e9rience industrielle et acad\u00e9mique dans divers secteurs de la s\u00e9curit\u00e9 des aliments et pharmaceutique.<\/span><\/p>\n<p><b>R\u00f4le<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Responsable de l&rsquo;\u00e9quipe R&amp;D compos\u00e9e de plus de 20 personnes d\u00e9di\u00e9es \u00e0 la chimie analytique (notamment experte en spectrom\u00e9trie de masse), il est aujourd&rsquo;hui Directeur de la Recherche en Chimie chez M\u00e9rieux NutriSciences. Il participe activement \u00e0 des projets scientifiques financ\u00e9s, \u00e0 des conf\u00e9rences scientifiques avec des pr\u00e9sentations, des posters et \u00e9crit des articles pour des revues scientifiques internationales.<\/span><\/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 &#8211; Chef de projets sp\u00e9ciaux Chimie<\/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><b>Background<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Dipl\u00f4m\u00e9 en g\u00e9nie chimique avec plus de 15 ans d&rsquo;exp\u00e9rience dans diff\u00e9rents secteurs dont 13 ans dans des installations BPF.<\/span><\/p>\n<p><b>R\u00f4le<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Responsable de l&rsquo;\u00e9quipe de validation BPF impliqu\u00e9e dans la validation des m\u00e9thodes selon les directives ICH ou d&rsquo;autres directives internationales conform\u00e9ment aux normes <\/span><span style=\"font-weight: 400;\">cGMP\/euGMP<\/span><span style=\"font-weight: 400;\"> ou BPL. <\/span><span style=\"font-weight: 400;\">Sp\u00e9cialiste de la validation de m\u00e9thodes de d\u00e9termination de stabilit\u00e9.<\/span><\/p>\n    \n                                                                                    <\/div>\n                    <\/div>\n                                    <\/div>\n    <\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"5184\" height=\"2795\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/09\/IMG_5610_mod-1.jpg\" alt=\"\" class=\"wp-image-113216\"\/><\/figure>\n<\/div><\/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\">Nos Services<\/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\"><strong>Test de confirmation &#8211; D\u00e9veloppement et validation de m\u00e9thodes<\/strong><\/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\"><strong>Analyses<\/strong> <strong>multir\u00e9sidus (petites nitrosamines)<\/strong><\/h4>\n\n\n<div class=\"wp-block-image\">\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;6a2067fb7efc0&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"6a2067fb7efc0\" 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--pointerdown=\"actions.preloadImage\" data-wp-on--pointerenter=\"actions.preloadImageWithDelay\" data-wp-on--pointerleave=\"actions.cancelPreload\" 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\tdata-wp-bind--aria-label=\"state.thisImage.triggerButtonAriaLabel\"\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.thisImage.buttonRight\"\n\t\t\tdata-wp-style--top=\"state.thisImage.buttonTop\"\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\"><strong>Analyse cibl\u00e9e sur les nitrosamines complexes (m\u00e9thodes disponibles pour +70 nitrosamines) &#8211; <em>liste non exhaustive<\/em><\/strong><\/h4>\n\n\n<div class=\"wp-block-image\">\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;6a2067fb7f643&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"6a2067fb7f643\" 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--pointerdown=\"actions.preloadImage\" data-wp-on--pointerenter=\"actions.preloadImageWithDelay\" data-wp-on--pointerleave=\"actions.cancelPreload\" 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\tdata-wp-bind--aria-label=\"state.thisImage.triggerButtonAriaLabel\"\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.thisImage.buttonRight\"\n\t\t\tdata-wp-style--top=\"state.thisImage.buttonTop\"\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\"><strong>D\u00e9pistage cible<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">D\u00e9pistage cibl\u00e9 par HRMS et\/ou MS\/HRMS (pour la d\u00e9tection de NI sans \u00e9talons de r\u00e9f\u00e9rence disponibles).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-nap-test\"><strong>Test NAP (Proc\u00e9dure de test de nitrosation)<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Le Test NAP  <\/strong>\u00e9value la formation potentielle de nitrosamines sp\u00e9cifiques dans un environnement nitrosant \u00e0 travers les techniques analytiques suivantes : LC\/MS\/MS et\/ou HRMS et\/ou MS\/HRMS et\/ou 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 class=\"wp-block-paragraph\">En 2024, l&rsquo;EFPIA (<em>European Federation of Pharmaceutical Industries and Associations<\/em>) a publi\u00e9 le document \u00ab <em><a href=\"https:\/\/www.efpia.eu\/media\/tkbnsicy\/efpia-nitrosamines-risk-management-workflows-jun-24-udpate.pdf\" target=\"_blank\" rel=\"noopener\">Drug Substance Workflow for Quality Risk Management of Nitrosamine Risks in Medicines<\/a> <\/em>\u00bb qui d\u00e9crit une nouvelle approche pour le Test NAP qui repr\u00e9sente les conditions pr\u00e9paratoires optimales \u00e0 la formation de nitrosamines devant \u00eatre examin\u00e9es. Ces orientations sont essentielles pour d\u00e9terminer si des nitrosamines peuvent se former dans les conditions sp\u00e9cifiques utilis\u00e9es dans la fabrication et le stockage des produits pharmaceutiques, \u00e9clairant ainsi les risques potentiels et leurs strat\u00e9gies de contr\u00f4le.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-risk-evaluation\"><strong>L&rsquo;\u00e9valuation des risques<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">D\u00e9pistage (ou tests quantitatifs) \u2013 r\u00e9alis\u00e9s selon les BPF ou non \u2013 sur les mati\u00e8res premi\u00e8res de produits pharmaceutiques, en appui au processus d\u2019\u00e9valuation des risques en cas d\u2019information insuffisante : analyse multir\u00e9siduelle de nitrosamines ou analyse cibl\u00e9e d\u2019une seule nitrosamine (avec ou sans \u00e9talon de r\u00e9f\u00e9rence).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-new-marketing-authorisation-and-batch-release\"><strong>Autorisation de mise sur le march\u00e9 et lib\u00e9ration des lots<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Tests quantitatifs multi-r\u00e9sidus en BPF pour d\u00e9montrer l\u2019absence de NI avant de demander une AMM<\/li>\n\n\n\n<li>Tests QC en GMP pour la lib\u00e9ration analytique des lots<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-alerts-management\">Gestion des alertes<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>D\u00e9veloppement et validation de la m\u00e9thode cible (service rush)<\/li>\n\n\n\n<li>Tests QC en GMP sur les API et DP du march\u00e9<\/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\">R\u00e9f\u00e9rences r\u00e9glementaires<\/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\">Que sont les nitrosamines ?<\/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 data-start=\"304\" data-end=\"508\">Les nitrosamines sont class\u00e9es parmi les substances <strong data-start=\"356\" data-end=\"398\">probablement canc\u00e9rog\u00e8nes pour l\u2019homme<\/strong>, ce qui signifie qu\u2019une exposition prolong\u00e9e au-del\u00e0 de certains seuils peut augmenter le risque de cancer.<\/p>\n<p data-start=\"514\" data-end=\"760\">Bien que des concentrations plus \u00e9lev\u00e9es de nitrosamines aient \u00e9t\u00e9 d\u00e9tect\u00e9es dans l\u2019alimentation et l\u2019eau potable que dans les m\u00e9dicaments, ces derni\u00e8res font n\u00e9anmoins l\u2019objet d\u2019une <strong data-start=\"697\" data-end=\"759\">surveillance continue de la part des autorit\u00e9s comp\u00e9tentes<\/strong>.<\/p>\n<p data-start=\"766\" data-end=\"1240\">Le 26 septembre 2019, le <strong data-start=\"791\" data-end=\"799\">CMDh<\/strong> (<em data-start=\"801\" data-end=\"881\">Coordination Group for Mutual Recognition and Decentralised Procedures \u2013 Human<\/em>) a publi\u00e9 un avis intitul\u00e9 <em data-start=\"909\" data-end=\"1015\">\u00ab Informations sur les nitrosamines \u00e0 destination des titulaires d\u2019autorisations de mise sur le march\u00e9 \u00bb<\/em>. Il y est demand\u00e9 \u00e0 tous les titulaires d\u2019AMM de m\u00e9dicaments \u00e0 usage humain contenant des <strong data-start=\"1106\" data-end=\"1154\">substances actives synth\u00e9tis\u00e9es chimiquement<\/strong> d\u2019\u00e9valuer le risque de pr\u00e9sence d\u2019impuret\u00e9s de type nitrosamines dans leurs produits.<\/p>\n<p data-start=\"1246\" data-end=\"1585\">\u00c0 la fin de l\u2019ann\u00e9e 2023, trois ann\u00e9es d\u2019\u00e9tudes et d\u2019investigations ont mis en \u00e9vidence une probl\u00e9matique plus complexe : la formation de <strong data-start=\"1384\" data-end=\"1444\">nitrosamines complexe (NDSRI)<\/strong>, dont l\u2019identification exige des <strong data-start=\"1478\" data-end=\"1503\">technologies avanc\u00e9es<\/strong> et une <strong data-start=\"1511\" data-end=\"1531\">expertise \u00e9lev\u00e9e<\/strong>, afin de garantir la s\u00e9curit\u00e9 des produits concern\u00e9s.<\/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\">Le processus d\u2019\u00e9valuation des risques<\/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                                                            <h5><b>PHASE 1 &#8211; \u00c9VALUATION DES RISQUES : <\/b><\/h5>\n<p><span style=\"font-weight: 400;\">Les titulaires d\u2019AMM doivent r\u00e9aliser une \u00e9valuation des risques des m\u00e9dicaments contenant des API issus de synth\u00e8ses chimiques et biologiques en utilisant les principes de qualit\u00e9 pour la gestion des risques, selon la ligne directrice ICH Q9 et les principes d\u00e9crits dans la ligne directrice ICH M7 sur l\u2019\u00e9valuation toxicologique et la strat\u00e9gie de contr\u00f4le. <\/span><\/p>\n<p>Une priorisation des produits est r\u00e9alis\u00e9e, et les m\u00e9dicaments identifi\u00e9s comme <strong data-start=\"808\" data-end=\"845\">\u00e0 haut risque ou \u00e0 forte priorit\u00e9<\/strong> (par exemple en cas d\u2019exposition quotidienne \u00e9lev\u00e9e ou d\u2019usage chronique) doivent faire l\u2019objet d\u2019une <strong data-start=\"948\" data-end=\"972\">\u00e9valuation imm\u00e9diate<\/strong>.<\/p>\n<p>Les <strong data-start=\"979\" data-end=\"1053\">rapports d\u2019\u00e9valuation des risques doivent \u00eatre disponibles sur demande<\/strong>.<br data-start=\"1054\" data-end=\"1057\" \/>Il est <strong data-start=\"1064\" data-end=\"1120\">d\u00e9conseill\u00e9 de soumettre des r\u00e9sultats pr\u00e9liminaires<\/strong> faisant \u00e9tat d\u2019un risque potentiel sans donn\u00e9es suffisantes, car <strong data-start=\"1186\" data-end=\"1284\">d\u00e8s lors qu\u2019un risque est identifi\u00e9, des tests de confirmation doivent \u00eatre engag\u00e9s sans d\u00e9lai<\/strong>.<\/p>\n<h5><b>PHASE 2 &#8211; TEST DE CONFIRMATION (le plus t\u00f4t possible apr\u00e8s l&rsquo;\u00e9valuation des risques en cas de risque identifi\u00e9)<\/b><\/h5>\n<p><b> Si un risque de pr\u00e9sence de nitrosamine est identifi\u00e9, des tests de confirmation utilisant des m\u00e9thodes valid\u00e9es et sensibles (BPF) sont requis. <\/b><span style=\"font-weight: 400;\">Les titulaires d&rsquo;AMM doivent informer imm\u00e9diatement les autorit\u00e9s comp\u00e9tentes si les tests confirment la pr\u00e9sence d&rsquo;une impuret\u00e9 nitrosamine, quelle que soit la quantit\u00e9 d\u00e9tect\u00e9e.<\/span><\/p>\n<h5><b>PHASE 3 &#8211; MODIFICATIONS DE L&rsquo;AUTORISATION DE MISE SUR LE MARCH\u00c9<\/b><\/h5>\n<p data-start=\"1855\" data-end=\"2056\">Lorsque des mesures correctives sont n\u00e9cessaires, les titulaires d\u2019AMM doivent <strong data-start=\"1934\" data-end=\"1990\">solliciter une d\u00e9rogation dans les d\u00e9lais appropri\u00e9s<\/strong>, afin de mettre en \u0153uvre les modifications requises, telles que :<\/p>\n<ul data-start=\"2057\" data-end=\"2159\">\n<li data-start=\"2057\" data-end=\"2106\">\n<p data-start=\"2059\" data-end=\"2106\">une <strong data-start=\"2063\" data-end=\"2105\">modification du proc\u00e9d\u00e9 de fabrication<\/strong>,<\/p>\n<\/li>\n<li data-start=\"2107\" data-end=\"2159\">\n<p data-start=\"2109\" data-end=\"2159\">ou une <strong data-start=\"2116\" data-end=\"2158\">r\u00e9vision des sp\u00e9cifications du produit<\/strong>.<\/p>\n<\/li>\n<\/ul>\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\n<h2 class=\"wp-block-heading\">Les technologies : <\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"273\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/08\/Extractables-and-leachables_eng_Tavola-disegno-1-1-768x373-1.jpg\" alt=\"\" class=\"wp-image-203823\" style=\"width:600px\" srcset=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/08\/Extractables-and-leachables_eng_Tavola-disegno-1-1-768x373-1.jpg 768w, https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/08\/Extractables-and-leachables_eng_Tavola-disegno-1-1-768x373-1-300x107.jpg 300w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/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<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\">Tous nos Services de Laboratoire Pharmaceutique |\u00a0D\u00e9couvrez nos Contenus<\/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-6e81cd72 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\">T\u00e9l\u00e9charger notre brochure<\/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-fe48e5de 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>T\u00e9l\u00e9charger<\/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\">D\u00e9couvrir  nos technologies<\/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-fe48e5de 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>D\u00e9couvrir la liste compl\u00e8te<\/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>D\u00e9couvrez nos autres services pour l\u2019Industrie Pharmaceutique :<\/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\/fr\/pharma\/controle-qualite-pharmaceutique\/\" class=\"card\">\n                                            <img decoding=\"async\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/08\/Senza-titolo-2-04-1.png\" alt=\"Contr\u00f4le qualit\u00e9 Pharmaceutique\" class=\"card-icon\"\/>\n                                        <div class=\"card-content\">\n                        <span>Contr\u00f4le qualit\u00e9 Pharmaceutique<\/span>\n                    <\/div>\n                <\/a>\n                                            <a href=\"https:\/\/www.merieuxnutrisciences.com\/fr\/pharma\/impuretes-pharmaceutiques\/\" class=\"card\">\n                                            <img decoding=\"async\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/08\/Analisi-delle-impurezze-blu.png\" alt=\"Impuret\u00e9s pharmaceutiques\" class=\"card-icon\"\/>\n                                        <div class=\"card-content\">\n                        <span>Impuret\u00e9s pharmaceutiques<\/span>\n                    <\/div>\n                <\/a>\n                                            <a href=\"https:\/\/www.merieuxnutrisciences.com\/fr\/pharma\/activites-rd-validation-pharmaceutique\/\" class=\"card\">\n                                            <img decoding=\"async\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/08\/RD-e-attivita-di-validazione-blu.png\" alt=\"R&amp;D et Validation de M\u00e9thodes pour l&rsquo;Industrie Pharmaceutique\" class=\"card-icon\"\/>\n                                        <div class=\"card-content\">\n                        <span>R&amp;D et Validation de M\u00e9thodes pour l&rsquo;Industrie Pharmaceutique<\/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: 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Structure et Capacit\u00e9s de Notre&#8230;<\/p>\n","protected":false},"author":43,"featured_media":177133,"parent":202375,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"service-page-pharma-blue.php","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"folder":[],"class_list":["post-203786","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"taxonomy_info":[],"featured_image_src_large":["https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/servizi-correlati_Nitrosammine-1-1024x581.jpg",1024,581,true],"author_info":{"display_name":"Morgan","author_link":"https:\/\/www.merieuxnutrisciences.com\/fr\/author\/morgan\/"},"comment_info":0,"_links":{"self":[{"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/pages\/203786","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/users\/43"}],"replies":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/comments?post=203786"}],"version-history":[{"count":16,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/pages\/203786\/revisions"}],"predecessor-version":[{"id":203894,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/pages\/203786\/revisions\/203894"}],"up":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/pages\/202375"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/media\/177133"}],"wp:attachment":[{"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/media?parent=203786"}],"wp:term":[{"taxonomy":"folder","embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/folder?post=203786"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}