{"id":4509,"date":"2026-09-17T08:23:58","date_gmt":"2026-09-17T08:23:58","guid":{"rendered":"https:\/\/nano-test.de\/?p=4509"},"modified":"2026-09-17T08:25:14","modified_gmt":"2026-09-17T08:25:14","slug":"analyse-von-bioziden-wirkstoffen-glp-konform","status":"publish","type":"post","link":"https:\/\/nano-test.de\/it\/2026\/09\/17\/analyse-von-bioziden-wirkstoffen-glp-konform\/","title":{"rendered":"Analisi dei principi attivi biocidi | Conforme a GLP"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4509\" class=\"elementor elementor-4509\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7852e204 ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7852e204\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7c5ba1e0 ts-bg-color-over-image\" data-id=\"7c5ba1e0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c2800cd elementor-widget elementor-widget-text-editor\" data-id=\"c2800cd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h1><span style=\"color: #000000;\">Analisi degli agenti di biocidi: Compliance BPR e soluzioni di nano test<\/span><\/h1>\n<p><span style=\"color: #000000;\">Biozidprodukte sind chemische oder biologische Pr\u00e4parate, die zur Abt\u00f6tung, Unsch\u00e4dlichmachung oder Bek\u00e4mpfung von Schadorganismen eingesetzt werden. Diese Produkte, die in 22 verschiedene Produkttypen eingeteilt werden \u2013 von Desinfektionsmitteln \u00fcber Sch\u00e4dlingsbek\u00e4mpfungsmittel bis hin zu Holzschutzmitteln und Antifouling-Farben \u2013, entfalten ihre Wirkung auf die Zielorganismen dank der darin enthaltenen <strong>Wirkstoffe<\/strong>. Die korrekte Identifizierung des Wirkstoffs, die genaue Bestimmung seiner Menge und der Nachweis der \u00dcbereinstimmung mit den angegebenen Spezifikationen sind sowohl f\u00fcr die Aufsichtsbeh\u00f6rden als auch f\u00fcr die Sicherheit der Endverbraucher von entscheidender Bedeutung.<\/span><\/p>\n<p><span style=\"color: #000000;\">L'ordinanza sui biocidi emanati dal Ministero della Salute turco prevede che i test da presentare nei documenti di domanda per principi attivi e biocidi debbano essere eseguiti secondo gli standard internazionali e i principi della buona pratica di laboratorio (GLP). Nell'Unione europea, le linee guida pubblicate dall'ECHA ai sensi del regolamento sui biocidi (BPR - 528\/2012) stabiliscono il quadro per l'analisi dei farmaci.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Importanza e portata dell'analisi dei farmaci<\/span><\/h2>\n<p><span style=\"color: #000000;\">Lo scopo principale dell'analisi dei farmaci nei biocidi \u00e8 verificare la conformit\u00e0 del prodotto alla composizione specificata. Queste analisi hanno lo scopo di fornire risposte alle seguenti domande:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Il principio attivo specificato nel prodotto \u00e8 effettivamente presente?<\/span><\/li>\n<li><span style=\"color: #000000;\">La concentrazione della sostanza attiva corrisponde al valore indicato sull'etichetta e nei documenti di approvazione?<\/span><\/li>\n<li><span style=\"color: #000000;\">Il prodotto contiene altri principi attivi non dichiarati o contaminanti dannosi?<\/span><\/li>\n<li><span style=\"color: #000000;\">La stabilit\u00e0 del principio attivo viene mantenuta per tutta la durata del prodotto?<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">La risposta a queste domande con metodi scientifici costituisce sia la base del processo di approvazione sia la base per il potere di verifica del prodotto nei controlli di mercato.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Selezione del metodo di analisi per tipo di principio attivo<\/span><\/h2>\n<p><span style=\"color: #000000;\">Quando si classificano i principi attivi biocidi in base ai loro gruppi funzionali chimici, la scelta del metodo di analisi diventa pi\u00f9 chiara. Diversi gruppi come composti fenolici, composti contenenti iodio, composti di ammonio quaternario, composti amminici, composti organometallici e perossidi richiedono diversi approcci analitici.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<p><span style=\"color: #000000;\"><b>1. Principi attivi non volatili: HPLC DAD<\/b><\/span><\/p>\n<p><span style=\"color: #000000;\">F\u00fcr nichtfl\u00fcchtige Wirkstoffe wie quart\u00e4re Ammoniumverbindungen (QACs), Biguanide und bestimmte organische S\u00e4uren ist die <strong>Cromatografia liquida pesante (HPLC)<\/strong> die bevorzugte Methode. In Kombination mit einem Diodenarray-Detektor (DAD) lassen sich sowohl quantitative Analysen als auch Unreinheitsprofile erstellen.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Untertitel --><\/span><\/p>\n<p><span style=\"color: #000000;\"><b>2. Agenti volatili: GC-FID\/ECD<\/b><\/span><\/p>\n<p><span style=\"color: #000000;\">F\u00fcr alkoholbasierte Desinfektionsmittel (Isopropanol, Ethanol) und bestimmte fl\u00fcchtige organische Verbindungen wird <strong>Gascromatografia (GC)<\/strong> eingesetzt. W\u00e4hrend der Flammenionisationsdetektor (FID) eine allgemeine Quantifizierung erm\u00f6glicht, bietet der Elektroneneinfangdetektor (ECD) eine hohe Empfindlichkeit f\u00fcr halogenierte Verbindungen.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<p><span style=\"color: #000000;\"><b>3. Analisi delle tracce: LC-MS\/MS e ICP-MS<\/b><\/span><\/p>\n<p><span style=\"color: #000000;\">F\u00fcr die Analyse des Verunreinigungsprofils und der R\u00fcckst\u00e4nde in Biozidprodukten werden <strong>LC-MS\/MS<\/strong> (organische Verunreinigungen) und <strong>ICP-MS<\/strong> (metallbasierte Wirkstoffe und Schwermetalle) eingesetzt. Diese Techniken bieten Nachweisgrenzen im ppb-Bereich (Teile pro Milliarde).<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<p><span style=\"color: #000000;\"><b>4. Analisi a 5 lotti (cinque lotti)<\/b><\/span><\/p>\n<p><span style=\"color: #000000;\">Per l'approvazione di un principio attivo nell'ambito del BPR, \u00e8 necessario analizzare campioni provenienti da almeno cinque diversi lotti per dimostrare la coerenza del processo di produzione. Questa analisi determina la purezza del principio attivo, il suo profilo di impurit\u00e0 e la variabilit\u00e0 del batch.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- Tabellenanfang --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Confronto dei metodi di analisi per principi attivi biocidi<\/span><\/h2>\n<p><span style=\"color: #000000;\">La tabella seguente riassume i metodi di base utilizzati nell'analisi dei farmaci nei prodotti biocidi:<\/span><\/p>\n<table>\n<thead>\n<tr>\n<th><span style=\"color: #000000;\">Metodo di analisi<\/span><\/th>\n<th><span style=\"color: #000000;\">Tipo adatto di ingrediente attivo<\/span><\/th>\n<th><span style=\"color: #000000;\">Limite di rilevamento<\/span><\/th>\n<th><span style=\"color: #000000;\">Ambito di applicazione<\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Pap\u00e0 HPLC<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">QAC, biguanidi, acidi organici<\/span><\/td>\n<td><span style=\"color: #000000;\">Area ppm<\/span><\/td>\n<td><span style=\"color: #000000;\">Determinazione di routine dei farmaci, profilo di contaminazione<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>GC-FID<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">Alcoli, composti organici volatili<\/span><\/td>\n<td><span style=\"color: #000000;\">Area ppm<\/span><\/td>\n<td><span style=\"color: #000000;\">Determinazione dei principi attivi nei disinfettanti<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>GC-ECD<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">Composti alogenati, pesticidi<\/span><\/td>\n<td><span style=\"color: #000000;\">Area PPB<\/span><\/td>\n<td><span style=\"color: #000000;\">Analisi del farmaco nell'area delle tracce<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>LC-MS\/MS<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">Composti polari e termicamente instabili<\/span><\/td>\n<td><span style=\"color: #000000;\">Area PPB-PPT<\/span><\/td>\n<td><span style=\"color: #000000;\">Identificazione di impurit\u00e0, analisi dei residui<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>ICP-MS<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">Principi attivi a base di metalli (argento, rame, zinco)<\/span><\/td>\n<td><span style=\"color: #000000;\">Area PPB<\/span><\/td>\n<td><span style=\"color: #000000;\">Determinazione di metalli pesanti e principi attivi metallici<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"color: #000000;\"><!-- Ende der Tabelle --><\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Regulatorischer Rahmen --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Analisi dei farmaci nell'ambito del BPR e della legislazione nazionale<\/span><\/h2>\n<p><span style=\"color: #000000;\">L'approvazione dei biocidi comprende un processo in due fasi: prima l'approvazione del principio attivo, quindi l'approvazione del prodotto contenente questo principio attivo. In entrambe le fasi, le analisi dei farmaci svolgono un ruolo cruciale.<\/span><\/p>\n<h3><span style=\"color: #000000;\">Fascicolo per l'approvazione di una sostanza attiva (approvazione della sostanza attiva)<\/span><\/h3>\n<p><span style=\"color: #000000;\">Per consentire un ingrediente attivo nel quadro del BPR, \u00e8 necessario dimostrare l'equivalenza tecnica (equivalenza tecnica). In questo contesto:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Vengono mostrate l'identit\u00e0 chimica e la struttura del principio attivo.<\/span><\/li>\n<li><span style=\"color: #000000;\">Il grado di purezza e il profilo di impurit\u00e0 sono determinati.<\/span><\/li>\n<li><span style=\"color: #000000;\">Viene eseguita un'analisi a 5 lotti con campioni di almeno cinque lotti.<\/span><\/li>\n<li><span style=\"color: #000000;\">I metodi analitici sono presentati completamente convalidati.<\/span><\/li>\n<\/ul>\n<h3><span style=\"color: #000000;\">Fascicolo di autorizzazione del prodotto (autorizzazione del prodotto)<\/span><\/h3>\n<p><span style=\"color: #000000;\">Per l'approvazione del prodotto, \u00e8 necessario dimostrare che il contenuto di principio attivo nel prodotto finito corrisponde al valore specificato. In questo contesto:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Nel prodotto finito viene determinata la quantit\u00e0 di principio attivo.<\/span><\/li>\n<li><span style=\"color: #000000;\">I test di stabilit\u00e0 vengono eseguiti per tutta la durata.<\/span><\/li>\n<li><span style=\"color: #000000;\">Vengono emessi certificati di analisi batch (COA).<\/span><\/li>\n<\/ul>\n<div class=\"note\"><span style=\"color: #000000;\"><strong>Wichtig:<\/strong> Die Analyse der in Biozidprodukten verwendeten Wirkstoffe muss in Laboren erfolgen, die den GLP-Grunds\u00e4tzen (Gute Laborpraxis) entsprechen. Andernfalls werden die erzielten Ergebnisse von den Aufsichtsbeh\u00f6rden nicht anerkannt.<\/span><\/div>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Nano-Test --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Analisi conformi a GLP di principi attivi in biocidi con nano-test<\/span><\/h2>\n<p><span style=\"color: #000000;\">Wirkstoffanalysen bilden f\u00fcr Hersteller von Biozidprodukten die Grundlage sowohl f\u00fcr das Zulassungsverfahren als auch f\u00fcr die Qualit\u00e4tskontrolle. <strong>Nano-Test<\/strong> ist mit seinen GLP-konformen Analysedienstleistungen in diesem Bereich ein zuverl\u00e4ssiger L\u00f6sungspartner f\u00fcr die Biozidbranche.<\/span><\/p>\n<div class=\"highlight\">\n<h3><span style=\"color: #000000;\">Nano test - Descrizione dei servizi<\/span><\/h3>\n<p><span style=\"color: #000000;\">Nano-Test bietet umfassende Dienstleistungen im Bereich der <strong>Wirkstoffanalysen (Active Ingredient Analyses)<\/strong> f\u00fcr Biozidprodukte an. In unseren nach GLP und ISO\/IEC 17025 akkreditierten Laboren werden Analysen durchgef\u00fchrt, die vollst\u00e4ndig den Anforderungen der BPR (528\/2012) und der nationalen Rechtsvorschriften entsprechen.<\/span><\/p>\n<p><span style=\"color: #000000;\">Il nostro portafoglio di servizi:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Bestimmung der Wirkstoffmenge:<\/strong> Pr\u00e4zise Quantifizierung mittels HPLC-DAD, GC-FID\/ECD, LC-MS\/MS und ICP-MS.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>5-Batch-Analyse:<\/strong> Technische \u00c4quivalenzstudien f\u00fcr das Zulassungsdossier des Wirkstoffs.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Profilo di contaminazione:<\/strong> Identifizierung und Quantifizierung relevanter Verunreinigungen.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Prove di stabilit\u00e0:<\/strong> \u00dcberwachung der Wirkstoffstabilit\u00e4t \u00fcber die gesamte Haltbarkeitsdauer.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Methodenentwicklung und -validierung:<\/strong> Validierungsstudien gem\u00e4\u00df ICH Q2(R2) und Q14.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Chargenanalysenzertifikate:<\/strong> Erstellung von CoA f\u00fcr jede Charge, die von den Zulassungsbeh\u00f6rden akzeptiert werden.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">Alle unsere Arbeiten werden unter Gew\u00e4hrleistung der Datenintegrit\u00e4t (ALCOA+-Prinzipien) durchgef\u00fchrt und als <strong>GLP-Konformit\u00e4tsberichte<\/strong> mit Pr\u00fcfungsgenehmigung vorgelegt.<\/span><\/p>\n<\/div>\n<h3><span style=\"color: #000000;\">Vantaggi del nano test nell'analisi degli agenti biocidi:<\/span><\/h3>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Breites Spektrum an Wirkstoffen:<\/strong> Validierte Methoden f\u00fcr QACs, Alkohole, Phenole, Organometalle und mehr.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>BPR-Konformit\u00e4t:<\/strong> Vollst\u00e4ndige \u00dcbereinstimmung mit den ECHA-Leitf\u00e4den und den BPR-Anh\u00e4ngen.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Schnelle Berichterstellung:<\/strong> Ergebnislieferung innerhalb von 5\u201310 Werktagen bei Standardanalysen.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>L\u00f6sung aus einer Hand:<\/strong> Wirkstoffbestimmung, Verunreinigungsprofil und Stabilit\u00e4tspr\u00fcfungen \u2013 alles unter einem Dach.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Fachkompetentes Team:<\/strong> Ein Team mit Erfahrung in der Biozid-Gesetzgebung und der analytischen Chemie.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Fazit --><\/span><\/p>\n<p><span style=\"color: #000000;\">Le analisi dei farmaci dei biocidi sono indispensabili per la sicurezza, l'efficacia e la conformit\u00e0 legale del prodotto. L'attuazione di queste analisi nell'ambito del BPR e della normativa nazionale in conformit\u00e0 ai principi GLP, con metodi convalidati e una corretta comunicazione \u00e8 un prerequisito per il buon funzionamento del processo di approvazione.<\/span><\/p>\n<p><span style=\"color: #000000;\">Con la sua infrastruttura analitica avanzata, i processi e gli specialisti certificati GLP, Nano-Test soddisfa pienamente i requisiti dei produttori di biocidi per l'analisi dei farmaci. Fai eseguire le tue analisi dei farmaci con la garanzia nano-test per dare ai tuoi prodotti un accesso regolare ai mercati globali.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Wirkstoffanalysen bei Biozidprodukten: BPR-Konformit\u00e4t und Nano-Test-L\u00f6sungen Biozidprodukte sind chemische oder biologische Pr\u00e4parate, die zur Abt\u00f6tung, Unsch\u00e4dlichmachung oder Bek\u00e4mpfung von Schadorganismen eingesetzt werden. Diese Produkte, die in 22 verschiedene Produkttypen eingeteilt werden \u2013 von Desinfektionsmitteln \u00fcber Sch\u00e4dlingsbek\u00e4mpfungsmittel bis hin zu Holzschutzmitteln und Antifouling-Farben \u2013, entfalten ihre Wirkung auf die Zielorganismen dank der darin enthaltenen Wirkstoffe. Die \u2026 <a href=\"https:\/\/nano-test.de\/it\/2026\/09\/17\/analyse-von-bioziden-wirkstoffen-glp-konform\/\" class=\"more-link\" title=\"Continue reading &lt;span class=\" screen-reader-text>Analyse von bioziden Wirkstoffen | GLP-konform\u201c&gt;Continue reading <span class=\"screen-reader-text\">Analisi dei principi attivi biocidi | Conforme a GLP<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":4510,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-4509","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biozid-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Analyse von bioziden Wirkstoffen | GLP-konform | Nano-Test\u00ae<\/title>\n<meta name=\"description\" content=\"Bestimmung von Wirkstoffen in Biozidprodukten, HPLC\/GC-Verfahren, 5-Batch-Analyse und ECHA\/BPR-Konformit\u00e4tsverfahren. 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