{"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\/en\/2026\/09\/17\/analyse-von-bioziden-wirkstoffen-glp-konform\/","title":{"rendered":"Analysis of biocidal active substances | GLP-compliant"},"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;\">Active substance analyses in biocidal products: BPR compliance and Nano-Test solutions<\/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;\">The regulation on biocidal products issued by the Turkish Ministry of Health stipulates that the tests to be submitted in the application files for active substances and biocidal products must be carried out in accordance with international standards and the principles of Good Laboratory Practice (GLP). In the European Union, the guidelines published by the ECHA within the framework of the Biocidal Products Regulation (BPR \u2013 528\/2012) set the framework for active substance analyses.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Significance and scope of active substance analysis<\/span><\/h2>\n<p><span style=\"color: #000000;\">The main purpose of active substance analysis in biocidal products is to verify that the product complies with the stated composition. These analyses should provide answers to the following questions:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Is the active substance stated in the product actually present?<\/span><\/li>\n<li><span style=\"color: #000000;\">Does the concentration of the active substance correspond to the value stated on the label and in the approval documents?<\/span><\/li>\n<li><span style=\"color: #000000;\">Does the product contain any other undeclared active substances or harmful impurities?<\/span><\/li>\n<li><span style=\"color: #000000;\">Is the stability of the active substance maintained throughout the entire shelf life of the product?<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">Answering these questions with scientific methods forms the basis of the approval process and the basis for the product's evidence in market controls.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Selection of the analysis method according to the type of active substance<\/span><\/h2>\n<p><span style=\"color: #000000;\">When classifying biocidal active substances according to their chemical functional groups, the choice of analysis method becomes clearer. Different groups such as phenolic compounds, iodine-containing compounds, quaternary ammonium compounds, amine-based compounds, organometallic compounds, and peroxides require different analytical approaches.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<p><span style=\"color: #000000;\"><b>1. Non-volatile active substances: 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>Heavy Duty Liquid Chromatography (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. Volatile active substances: 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>Gas Chromatography (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. Trace analyses: LC-MS\/MS and 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. 5-Batch analysis (Five batches)<\/b><\/span><\/p>\n<p><span style=\"color: #000000;\">For the approval of an active substance within the framework of the BPR, samples from at least five different batches must be analyzed to prove the consistency of the manufacturing process. This analysis determines the purity of the active substance, its impurity profile, and batch variability.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- Tabellenanfang --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Comparison of analysis methods for biocidal active substances<\/span><\/h2>\n<p><span style=\"color: #000000;\">The following table summarizes the basic methods used in the analysis of active substances in biocidal products:<\/span><\/p>\n<table>\n<thead>\n<tr>\n<th><span style=\"color: #000000;\">Analysis method<\/span><\/th>\n<th><span style=\"color: #000000;\">Suitable active substance type<\/span><\/th>\n<th><span style=\"color: #000000;\">Limit of detection<\/span><\/th>\n<th><span style=\"color: #000000;\">Scope of application<\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><span style=\"color: #000000;\"><strong>HPLC dad<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">QACs, Biguanide, organic acids<\/span><\/td>\n<td><span style=\"color: #000000;\">ppm range<\/span><\/td>\n<td><span style=\"color: #000000;\">Routine active substance determination, impurity profile<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>GC-FID<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">Alcohols, volatile organic compounds<\/span><\/td>\n<td><span style=\"color: #000000;\">ppm range<\/span><\/td>\n<td><span style=\"color: #000000;\">Determination of active substances in disinfectants<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>GC-ECD<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">Halogenated compounds, pesticides<\/span><\/td>\n<td><span style=\"color: #000000;\">ppb range<\/span><\/td>\n<td><span style=\"color: #000000;\">Active substance analysis in the trace range<\/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;\">Polar and thermally unstable compounds<\/span><\/td>\n<td><span style=\"color: #000000;\">ppb-ppt range<\/span><\/td>\n<td><span style=\"color: #000000;\">Identification of impurities, residue analysis<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>ICP-MS<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">Active substances based on metals (silver, copper, zinc)<\/span><\/td>\n<td><span style=\"color: #000000;\">ppb range<\/span><\/td>\n<td><span style=\"color: #000000;\">Determination of heavy metals and metallic active substances<\/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;\">Active substance analyses within the framework of the BPR and national regulations<\/span><\/h2>\n<p><span style=\"color: #000000;\">The authorization of biocidal products involves a two-stage process: first, the authorization of the active substance, then the authorization of the product containing this active substance. In both phases, active substance analyses play a crucial role.<\/span><\/p>\n<h3><span style=\"color: #000000;\">Dossier for the authorization of an active substance (Active Substance Approval)<\/span><\/h3>\n<p><span style=\"color: #000000;\">For an active substance to be authorized under the BPR, technical equivalence (technical equivalence) must be demonstrated. In this context:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">The chemical identity and structure of the active substance are shown.<\/span><\/li>\n<li><span style=\"color: #000000;\">The purity and impurity profile are determined.<\/span><\/li>\n<li><span style=\"color: #000000;\">A 5-batch analysis with samples from at least five batches is performed.<\/span><\/li>\n<li><span style=\"color: #000000;\">The analytical methods are fully validated and presented.<\/span><\/li>\n<\/ul>\n<h3><span style=\"color: #000000;\">Product authorization dossier (Product Authorisation)<\/span><\/h3>\n<p><span style=\"color: #000000;\">For product authorization, it must be demonstrated that the active substance content in the finished product is in agreement with the specified value. In this context:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">The active substance quantity is determined in the finished product.<\/span><\/li>\n<li><span style=\"color: #000000;\">Stability tests are carried out over the entire shelf life.<\/span><\/li>\n<li><span style=\"color: #000000;\">Certificates of analysis (CoA) are issued.<\/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;\">GLP-compliant analysis of active substances in biocidal products with 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 \u2013 Performance Description<\/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;\">Our service portfolio:<\/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>Contamination profile:<\/strong> Identifizierung und Quantifizierung relevanter Verunreinigungen.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Stress tests:<\/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;\">Advantages of Nano-Test in the analysis of biocidal active substances:<\/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;\">Active substance analyses in biocidal products are indispensable for the safety, efficacy, and regulatory compliance of the product. The performance of these analyses within the framework of the BPR and national regulations, in compliance with GLP principles, with validated methods and correct reporting, is a prerequisite for a smooth authorization procedure.<\/span><\/p>\n<p><span style=\"color: #000000;\">Nano-Test meets the requirements of biocidal product manufacturers for active substance analysis with its advanced analytical infrastructure, GLP-certified processes, and specialist staff. Have your active substance analyses carried out with the guarantee of Nano-Test to enable your products to have smooth access to global markets.<\/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\/en\/2026\/09\/17\/analyse-von-bioziden-wirkstoffen-glp-konform\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Analyse von bioziden Wirkstoffen | GLP-konform\u201c&gt;Continue reading <span class=\"screen-reader-text\">Analysis of biocidal active substances | GLP-compliant<\/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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