{"id":111912,"date":"2024-08-23T08:17:55","date_gmt":"2024-08-23T07:17:55","guid":{"rendered":"https:\/\/test.merieuxnutrisciences.com\/?page_id=111912"},"modified":"2026-02-13T14:51:56","modified_gmt":"2026-02-13T14:51:56","slug":"identificazione-delle-nitrosammine","status":"publish","type":"page","link":"https:\/\/www.merieuxnutrisciences.com\/it\/pharma-healthcare\/farmaceutici\/identificazione-delle-nitrosammine\/","title":{"rendered":"Ricerca Nitrosammine"},"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\/2024\/09\/shutterstock_279021860_Nitrosammine-1-1.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\/2024\/08\/Identificazione-delle-Nitrosammine-bianco.png\" alt=\"Icon\" \/>\n                <\/div>\n                        <h1>Ricerca Nitrosammine<\/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<p>Il&nbsp;<strong>servizio globale<\/strong>&nbsp;per l\u2019analisi di nitrosammine in M\u00e9rieux NutriSciences | Pharma &amp; HealthCare. Il laboratorio dedicato all\u2019analisi delle nitrosammine \u00e8 un centro di eccellenza che combina avanzate tecnologie scientifiche e competenze specialistiche per garantire la sicurezza dei prodotti farmaceutici. Questo laboratorio \u00e8 dotato di una vasta gamma di strumentazioni all\u2019avanguardia e risorse umane altamente qualificate.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-struttura-e-capacita-del-laboratorio\">Struttura e capacit\u00e0 del laboratorio<\/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\">Esperienza e competenze<\/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>Vanta oltre 15 anni di esperienza nell\u2019analisi e studio di nitrosammine in diversi settori.<\/li>\n<li>Sono presenti pi\u00f9 di 25 specialisti dedicati esclusivamente allo studio delle nitrosammine, con competenze specifiche e avanzate in questo settore.<\/li>\n<li>Sono stati sviluppati oltre 70 metodi per l\u2019analisi di NDSRIs (Nitrosamine drug substance-related impurities).<\/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\">Tecnologie e attrezzature<\/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>Dispone di pi\u00f9 di 6 diverse tecniche analitiche, tra cui spettrometri di massa (HRMS, MS\/MS) accoppiati a sistemi cromatografici ad alta prestazione, essenziali per rilevare anche le pi\u00f9 piccole tracce di nitrosammine nei prodotti.<\/li>\n<li>Dotato di 7 LC\/MS-MS dedicati esclusivamente ai test sulle nitrosammine.<\/li>\n<li>Il laboratorio ha eseguito pi\u00f9 di 15.000 test per la ricerca di svariate nitrosammine su prodotti farmaceutici<\/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\">Infrastruttura e ambiente<\/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>Il laboratorio \u00e8 situato in una struttura moderna che ospita 3 differenti dipartimenti, ognuno dedicato a specifiche aree di ricerca e analisi.<\/li>\n<li>L\u2019ambiente di lavoro \u00e8 stato progettato per favorire la collaborazione interdisciplinare tra team, assicurando un approccio integrato e completo alle analisi.<\/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\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"2880\" height=\"1027\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/09\/shutterstock_2130175733-NI-LAB_2024-01.jpg\" alt=\"\" class=\"wp-image-114375\"\/><\/figure>\n\n\n\n<div style=\"height:31px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-le-tappe-fondamentali-raggiunte-da-merieux-nutrisciences-pharma-amp-healthcare\"><strong>Le tappe fondamentali raggiunte da M\u00e9rieux NutriSciences | Pharma &amp; HealthCare<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"2003\" height=\"1029\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/08\/nitrosammine-mappa.jpg\" alt=\"\" class=\"wp-image-111913\"\/><\/figure>\n\n\n\n<div style=\"height:49px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h1 class=\"wp-block-heading\" id=\"h-confirmatory-test-sviluppo-e-convalida-metodi\">Confirmatory test: sviluppo e convalida metodi<\/h1>\n\n\n\n<div style=\"height:19px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-analisi-multiresiduale-set-standard\">Analisi multiresiduale (set standard)<\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"184\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-15_Tavola-disegno-1-1024x184.jpg\" alt=\"Multiresidual Analysis\" class=\"wp-image-177274\" srcset=\"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-1-300x54.jpg 300w, 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: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<div style=\"height:33px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-analisi-target-70-nitrosammine-specifiche-su-richiesta-ricerca-e-sviluppo-elenco-non-esaustivo\">Analisi target (+ 70 nitrosammine specifiche su richiesta \/ ricerca e sviluppo) &#8211; <em>elenco non esaustivo<\/em>.<\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"510\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/Schema-nitro-70_Tavola-disegno-1-1024x510.jpg\" alt=\"Target Methods\" class=\"wp-image-177256\" srcset=\"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-1-300x149.jpg 300w, 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: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-target-screening\"><strong>Target Screening<\/strong><\/h2>\n\n\n\n<p><strong>Target Screening<\/strong> mediante HRMS e\/o MS\/HRMS (per il rilevamento di NI senza standard di riferimento disponibili).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-nap-test\"><strong>NAP Test<\/strong><\/h2>\n\n\n\n<p><strong>NAP TEST <\/strong>residuale qualitativo \/ analisi in tracce per valutare la potenziale formazione di nitrosammine specifiche in ambiente nitrosante attraverso le seguenti tecniche analitiche: LC\/MS\/MS e\/o HRMS e\/o MS\/HRMS e\/o UV. <\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><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;width:869px;height:auto\" 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<p><br>Nel 2024, l&#8217;EFPIA (<em>European Federation of Pharmaceutical Industries and Associations<\/em>) ha pubblicato il documento \u201c<em><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><\/em>\u201d che descrive un nuovo approccio per il NAP test il quale rappresenta le condizioni preparatorie ottimali per la formazione di nitrosammine che dovrebbero essere esaminate. Questa guida \u00e8 essenziale per determinare se le nitrosammine possono formarsi nelle condizioni specifiche utilizzate nella produzione e nella conservazione di sostanze e prodotti farmaceutici, informando cos\u00ec le valutazioni del rischio e le strategie di controllo.<\/p>\n\n\n<style>.wp-block-kadence-advancedbtn.kb-btns111912_106de7-62{gap:var(--global-kb-gap-xs, 0.5rem );justify-content:center;align-items:center;}.kt-btns111912_106de7-62 .kt-button{font-weight:normal;font-style:normal;}.kt-btns111912_106de7-62 .kt-btn-wrap-0{margin-right:5px;}.wp-block-kadence-advancedbtn.kt-btns111912_106de7-62 .kt-btn-wrap-0 .kt-button{color:#555555;border-color:#555555;}.wp-block-kadence-advancedbtn.kt-btns111912_106de7-62 .kt-btn-wrap-0 .kt-button:hover, .wp-block-kadence-advancedbtn.kt-btns111912_106de7-62 .kt-btn-wrap-0 .kt-button:focus{color:#ffffff;border-color:#444444;}.wp-block-kadence-advancedbtn.kt-btns111912_106de7-62 .kt-btn-wrap-0 .kt-button::before{display:none;}.wp-block-kadence-advancedbtn.kt-btns111912_106de7-62 .kt-btn-wrap-0 .kt-button:hover, .wp-block-kadence-advancedbtn.kt-btns111912_106de7-62 .kt-btn-wrap-0 .kt-button:focus{background:#444444;}<\/style>\n<div class=\"wp-block-kadence-advancedbtn kb-buttons-wrap kb-btns111912_106de7-62\"><style>ul.menu .wp-block-kadence-advancedbtn .kb-btn111912_f9a883-92.kb-button{width:initial;}<\/style><a class=\"kb-button kt-button button kb-btn111912_f9a883-92 kt-btn-size-standard kt-btn-width-type-auto kb-btn-global-outline  kt-btn-has-text-true kt-btn-has-svg-false  wp-block-kadence-singlebtn\" href=\"https:\/\/drive.google.com\/file\/d\/1BL9eRcySDUsNnwXj9GYkzfETycA3kX9N\/view\" target=\"_blank\" rel=\"noopener\"><span class=\"kt-btn-inner-text\">Scarica la brochure<\/span><\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-valutazione-del-rischio\">Valutazione del rischio<\/h2>\n\n\n\n<p>Screening dei limiti o test quantitativi \u2013 GMP o non-GMP \u2013 su materie prime di prodotti farmaceutici a supporto del processo di valutazione del rischio in caso di carenza di informazioni: analisi NI multiresiduale o analisi NI singola (con o senza standard di riferimento).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-nuova-autorizzazione-all-immissione-in-commercio-e-rilascio-lotto\">Nuova autorizzazione all\u2019immissione in commercio e rilascio lotto<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\">Test quantitativi multiresiduali in GMP per dimostrare l\u2019assenza di NI prima di richiedere una nuova autorizzazione all\u2019immissione in commercio<\/li>\n\n\n\n<li style=\"font-size:18px\">Prove di QC in GMP per il rilascio analitico dei lotti<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-gestione-delle-allerte\">Gestione delle allerte<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:18px\">Sviluppo e convalida del metodo target (servizio rush)<\/li>\n\n\n\n<li style=\"font-size:18px\">Test QC in GMP su API e DP presenti sul mercato<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-risk-assessment\">Risk assessment<\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/www.merieuxnutrisciences.com\/eu\/wp-content\/uploads\/2024\/10\/Bandone_Riferimenti-normativi.jpg\" alt=\"\" class=\"wp-image-118198\"\/><\/figure>\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\">Cosa sono le nitrosammine?<\/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>Le nitrosamine sono classificate come <strong>probabili agenti cancerogeni<\/strong>\u00a0per l\u2019uomo, ci\u00f2 implica che l\u2019esposizione oltre certi livelli e a lungo termine, potrebbe aumentare il rischio di insorgenza del cancro. Le nitrosammine presenti in alimenti e acqua potabile sono risultate essere pi\u00f9 elevate rispetto ai livelli riscontarti nei farmaci, dove comunque continuano ad essere monitorate dalle autorit\u00e0 competenti.<\/p>\n<p>Il 26 settembre 2019, il <strong>CMDh<\/strong> (Heads of Medicines Agencies) ha pubblicato l&#8217;avviso &#8220;Informazioni sulle nitrosamine per i titolari di autorizzazione all&#8217;immissione in commercio&#8221;, chiedendo a <strong>tutti i titolari di autorizzazione all&#8217;immissione in commercio (MAH) di medicinali per uso umano contenenti principi attivi chimicamente sintetizzati di valutare il rischio della presenza di impurezze nitrosamminiche nei loro prodotti<\/strong>.<\/p>\n<p>Alla fine del 2023, i tre anni di studio e ricerca hanno rivelato un <strong>problema molto pi\u00f9 pressante<\/strong> causato dalla <strong>formazione di nitrosamine complesse<\/strong> (NDSRIs) che richiedono alti livelli di competenza e tecnologia per essere rilevate, al fine di garantire la sicurezza del prodotto.<\/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\">Il processo di valutazione del rischio<\/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>FASE 1 &#8211; VALUTAZIONE DEL RISCHIO<br \/>\n<\/strong>I MAH devono eseguire la valutazione del rischio dei medicinali contenenti API derivati da sintesi chimica e biologica utilizzando i principi della qualit\u00e0 per la gestione del rischio, secondo la linea guida ICH Q9 e i principi descritti nella linea guida ICH M7 relativa alla valutazione tossicologica e alla strategia di controllo. La priorit\u00e0 dei prodotti \u00e8 stabilita e la valutazione del rischio dei prodotti ad alto rischio\/alta priorit\u00e0 deve essere effettuata immediatamente (ad es. maggiore esposizione giornaliera e uso cronico). I documenti di valutazione del rischio devono essere resi disponibili su richiesta.<br \/>\nSi dovrebbe evitare di presentare risultati di <strong>valutazione del rischio <\/strong>preliminari che menzionino un rischio potenziale a causa della mancanza di dati certi, poich\u00e9 se il modello \u00e8 completato con un rischio potenziale identificato, i test di conferma devono essere avviati immediatamente.<\/p>\n<p><strong>FASE 2 &#8211; CONFIRMATORY TEST<br \/>\n<\/strong><strong>Al pi\u00f9 presto dopo la valutazione del rischio in caso di rischio identificato. Se viene identificato un rischio di presenza di nitrosammine, allora sono richiesti test di conferma con l\u2019uso di metodi convalidati e sensibili (GMP)<\/strong>. Le MAH devono informare immediatamente le autorit\u00e0 competenti se i test confermano la presenza di un\u2019impurezza nitrosamminica, indipendentemente dalla quantit\u00e0 rilevata.<\/p>\n<p><strong>FASE 3 &#8211; MODIFICHE DELL\u2019AUTORIZZAZIONE ALL\u2019IMMISSIONE IN COMMERCIO.<br \/>\n<\/strong>I MAH dovrebbero richiedere una variazione in modo tempestivo per introdurre le modifiche richieste, come la modifica del processo di produzione o le modifiche alle specifiche del prodotto.<\/p>\n    \n                                                                                    <\/div>\n                    <\/div>\n                                    <\/div>\n    \n\n\n<div style=\"height:28px\" 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\/1-0Ymnxz2q8gTc2ywzuD5Pgx6A3x5UCUG\/view?usp=drive_link\" target=\"_blank\" rel=\"noopener\"><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\" \/><\/a><\/figure>\n<\/div>\n\n\n<div style=\"height:38px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h1 class=\"wp-block-heading\" id=\"h-vuoi-ricevere-la-nostra-presentazione-completa-sulle-nitrosammine\">Vuoi ricevere la nostra presentazione completa sulle nitrosammine?<\/h1>\n\n\n\n<p>Compila il form sottostante per riceverla!<\/p>\n\n\n<noscript class=\"ninja-forms-noscript-message\">\n\tAvviso: JavaScript \u00e8 obbligatorio per questo contenuto.<\/noscript>\n<style>\n\n        \/* PLUGIN WIDE STYLES *\/\n    \n        .nf-form-title h3 {\n                                    color:#0a4479;\n                    }\n    <\/style><style>\n\n        \/* FIELDS STYLES *\/\n    \n        .nf-form-content .nf-field-container #nf-field-1805-wrap .nf-field-element .ninja-forms-field {\n                                    background-color:#afcc46;\n                                            color:#ffffff;\n                    }\n        .nf-form-content .nf-field-container #nf-field-1805-wrap .nf-field-element .ninja-forms-field:hover {\n                                    background-color:#00abe6;\n                                            color:#0a4479;\n                    }\n    <\/style><div id=\"nf-form-134-cont\" class=\"nf-form-cont\" aria-live=\"polite\" aria-labelledby=\"nf-form-title-134\" aria-describedby=\"nf-form-errors-134\" role=\"form\">\n\n    <div class=\"nf-loading-spinner\"><\/div>\n\n<\/div>\n        <!-- That data is being printed as a workaround to page builders reordering the order of the scripts loaded-->\n        <script>var formDisplay=1;var nfForms=nfForms||[];var form=[];form.id='134';form.settings={\"objectType\":\"Form Setting\",\"editActive\":true,\"title\":\"2025 - Pharma &amp; 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\n    height: auto;\n    margin-bottom: 10px;\n}\n.card-content{\n    display:flex;\n    justify-content: center;\n}\n\n.card-content span{\n    color:var(--global-palette3);\n    text-align: center;\n    text-transform: uppercase;\n    margin: 5px 0;\n    line-height: 1.2em;\n    font-size: 16px;\n    font-weight:bold;\n}\n\n.card:hover {\n    animation: all ease-in-out 0.3s;\n    transform: scale(.95) translate(0px, -100px);\n    box-shadow: 0 4px 8px rgba(0,0,0,0.2);\n}\n\n@media (max-width: 767px) {\n    .page-cards-container {\n        flex-direction: column;\n        align-items: center;\n    }\n    .page-cards-title-container{\n        text-align: center;\n    }\n    \n}\n\n@media (min-width: 768px) and (max-width: 1023px) {\n    .page-cards-container {\n        flex-wrap: wrap;\n        justify-content: space-around;\n    }\n    .page-cards-title-container{\n        text-align: center;\n    }\n\n}\n\n<\/style>\n","protected":false},"excerpt":{"rendered":"<p>Il&nbsp;servizio globale&nbsp;per l\u2019analisi di nitrosammine in M\u00e9rieux NutriSciences | Pharma &amp; HealthCare. Il laboratorio dedicato all\u2019analisi delle nitrosammine \u00e8 un centro di eccellenza che combina avanzate tecnologie scientifiche e competenze specialistiche per garantire la sicurezza dei prodotti farmaceutici. Questo laboratorio \u00e8 dotato di una vasta gamma di strumentazioni all\u2019avanguardia e risorse umane altamente qualificate. Struttura&#8230;<\/p>\n","protected":false},"author":39,"featured_media":113247,"parent":110910,"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-111912","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"taxonomy_info":[],"featured_image_src_large":["https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/09\/shutterstock_279021860_Nitrosammine-1-1.jpg",1024,372,false],"author_info":{"display_name":"Alberto Asquini","author_link":"https:\/\/www.merieuxnutrisciences.com\/it\/author\/albertoa\/"},"comment_info":0,"_links":{"self":[{"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/pages\/111912","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/comments?post=111912"}],"version-history":[{"count":9,"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/pages\/111912\/revisions"}],"predecessor-version":[{"id":260023,"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/pages\/111912\/revisions\/260023"}],"up":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/pages\/110910"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/media\/113247"}],"wp:attachment":[{"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/media?parent=111912"}],"wp:term":[{"taxonomy":"folder","embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/folder?post=111912"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}