{"id":4453,"date":"2026-08-26T12:16:02","date_gmt":"2026-08-26T12:16:02","guid":{"rendered":"https:\/\/nano-test.de\/?p=4453"},"modified":"2026-08-26T12:23:01","modified_gmt":"2026-08-26T12:23:01","slug":"in-vivo-pruefungen-an-medizinprodukten-biokompatibilitaet","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2026\/08\/26\/in-vivo-pruefungen-an-medizinprodukten-biokompatibilitaet\/","title":{"rendered":"In-Vivo Tests on Medical Devices: Biocompatibility"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4453\" class=\"elementor elementor-4453\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1b4fc934 ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b4fc934\" 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-1b95954 ts-bg-color-over-image\" data-id=\"1b95954\" 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-39e82139 elementor-widget elementor-widget-text-editor\" data-id=\"39e82139\" 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;\">GLP Identity Tests and Nano Test Solutions for Pharmaceutical Products<\/span><\/h1><p><span style=\"color: #000000;\">In der pharmazeutischen Industrie sind Patientensicherheit und Produktqualit\u00e4t zweifellos die beiden wichtigsten Faktoren. Ein Arzneimittel muss vor der Markteinf\u00fchrung und in jeder Phase des Herstellungsprozesses \u00fcberpr\u00fcft werden. Genau an dieser Stelle kommen die <strong>GLP-Identit\u00e4tspr\u00fcfungen f\u00fcr <a href=\"https:\/\/nano-test.de\/en\/service\/pharma\/\">pharmazeutische Produkte<\/a><\/strong> (Identity Tests) ins Spiel. Die Gute Laborpraxis (Good Laboratory Practice \u2013 GLP) ist ein Qualit\u00e4tssystem, das gew\u00e4hrleistet, dass diese Pr\u00fcfungen zuverl\u00e4ssig, wiederholbar und gem\u00e4\u00df internationaler Standards durchgef\u00fchrt werden.<\/span><\/p><p><span style=\"color: #000000;\">The \"identity\" of a pharmaceutical product refers to its molecular structure, chemical formula and physical properties. Using a false raw material or cross-contamination in the production line can lead to irreparable consequences. Therefore, the identity checks carried out as part of the GLP serve to analytically prove that the product is actually the \"desired active ingredient\".<\/span><\/p><p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p><h2><span style=\"color: #000000;\">The importance of identity checks in pharmaceutical products<\/span><\/h2><p><span style=\"color: #000000;\">Identity checks are not only an analysis, but also a legal obligation. Regulators such as the FDA, EMA and T\u0130TCK require proof that these tests have been carried out in accordance with the GLP principles in the case of approval requests and, through routine quality controls. Without identity verification, the release (release) of a product is not possible.<\/span><\/p><p><span style=\"color: #000000;\">GLP standards set strict regulations in areas such as personnel training, device calibration, standard work instructions (SOP) and data integrity. As a result, the results achieved are internationally recognized. These tests also play an important role in combating counterfeit medicines and ensuring security in the supply chain.<\/span><\/p><p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p><h2><span style=\"color: #000000;\">Basic analytical methods within the framework of the GLP<\/span><\/h2><p><span style=\"color: #000000;\">Several analytical techniques can be combined to identify a pharmaceutical product or a pharmaceutical agent (API). The choice of method depends on the structure of the molecule and the respective pharmacopoeia monograph (e.g. USP, European pharmacopoeia).<\/span><\/p><p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p><h3><span style=\"color: #000000;\">1. Spectroscopic Procedures<\/span><\/h3><ul><li><span style=\"color: #000000;\"><strong>Fourier-Transform-Infrarotspektroskopie (FTIR):<\/strong> Gilt als \u201eFingerabdruck\u201c des Molek\u00fcls. Durch die Analyse der Schwingungsbanden der funktionellen Gruppen wird nachgewiesen, dass die Substanz mit dem Standardreferenzmaterial identisch ist.<\/span><\/li><li><span style=\"color: #000000;\"><strong>UV-Vis-Spektralphotometrie:<\/strong> Misst insbesondere die Absorption von Molek\u00fclen, die Chromophorgruppen enthalten, bei bestimmten Wellenl\u00e4ngen.Ideal f\u00fcr schnelle Screenings.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Kernspinresonanz (NMR):<\/strong> Die leistungsst\u00e4rkste Technik zur Aufkl\u00e4rung der Molek\u00fclstruktur. Wird in GLP-Studien insbesondere zur Verifizierung komplexer Molek\u00fcle eingesetzt.<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p><h3><span style=\"color: #000000;\">2. Chromatographic Methods<\/span><\/h3><ul><li><span style=\"color: #000000;\"><strong>Heavy Duty Liquid Chromatography (HPLC):<\/strong> Die Identifizierung erfolgt in der Regel durch einen Vergleich der Retentionszeiten.<\/span><\/li><li><span style=\"color: #000000;\"><strong>D\u00fcnnschichtchromatographie (TLC):<\/strong> Sie ist eine kosteng\u00fcnstige und effektive Methode, insbesondere zur Identifizierung von Produkten pflanzlichen Ursprungs und bestimmter Hilfsstoffe.<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p><h3><span style=\"color: #000000;\">3. Thermal Analysis and Miscellaneous<\/span><\/h3><ul><li><span style=\"color: #000000;\"><strong>Differential Scanning Calorimetry (DSC):<\/strong> Sie ist von entscheidender Bedeutung bei der Analyse von Polymorphismen (unterschiedliche Kristallstrukturen desselben Molek\u00fcls).<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><!-- Tabellenanfang --><\/span><\/p><h2><span style=\"color: #000000;\">Comparison of the methods used in GLP identity checks<\/span><\/h2><p><span style=\"color: #000000;\">Die folgende Tabelle fasst die grundlegenden Merkmale der im Rahmen der <strong>GLP-Identit\u00e4tspr\u00fcfungen f\u00fcr Arzneimittel<\/strong> am h\u00e4ufigsten verwendeten Methoden zusammen:<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Analytical Method<\/span><\/th><th><span style=\"color: #000000;\">Measuring principle<\/span><\/th><th><span style=\"color: #000000;\">Advantages<\/span><\/th><th><span style=\"color: #000000;\">Typical scope<\/span><\/th><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\"><strong>For<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Molecular Vibration Bands<\/span><\/td><td><span style=\"color: #000000;\">Fast, non-destructive, high specificity<\/span><\/td><td><span style=\"color: #000000;\">Verification of raw materials and finished products<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>HPLC<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Chromatographic Separation + Detector<\/span><\/td><td><span style=\"color: #000000;\">High sensitivity, can be combined with quantity determination<\/span><\/td><td><span style=\"color: #000000;\">Purity and identity determination of active ingredients<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Dsc<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Heat flow difference (melting\/crystallization)<\/span><\/td><td><span style=\"color: #000000;\">Detection of polymorphic and amorphous structures<\/span><\/td><td><span style=\"color: #000000;\">Solid dosage forms, physical stability<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>NMR<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Magnetic resonance of atomic nuclei<\/span><\/td><td><span style=\"color: #000000;\">Precise structure determination, versatility<\/span><\/td><td><span style=\"color: #000000;\">Unknown impurities, registration of new molecules<\/span><\/td><\/tr><\/tbody><\/table><p><span style=\"color: #000000;\"><!-- Ende der Tabelle --><\/span><\/p><p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Nano-Test --><\/span><\/p><h2><span style=\"color: #000000;\">GLP compliant identity checks with nano test<\/span><\/h2><p><span style=\"color: #000000;\">Angesichts der zunehmenden Beschleunigung der Arzneimittelentwicklungsprozesse ist es das vorrangige Ziel, keine Kompromisse bei der Genauigkeit der Analyseergebnisse einzugehen. <strong>Nano-Test<\/strong> zeichnet sich mit seiner fortschrittlichen technologischen Infrastruktur und seinem Fachpersonal als zuverl\u00e4ssiger Partner f\u00fcr GLP-konforme Identit\u00e4tspr\u00fcfungen in der pharmazeutischen Industrie aus.<\/span><\/p><div class=\"highlight\"><h3><span style=\"color: #000000;\">Nano-Test \u2013 Performance Description<\/span><\/h3><p><span style=\"color: #000000;\">Nano-Test erbringt seine Dienstleistungen in Laboren, die mit modernsten Analyseger\u00e4ten ausgestattet sind und den Standards der Guten Laborpraxis (GLP) sowie der Norm ISO\/IEC 17025 vollst\u00e4ndig entsprechen. Unser Leistungsportfolio umfasst Identit\u00e4tspr\u00fcfungen gem\u00e4\u00df allen Pharmakop\u00f6e-Monografien, darunter <strong>FTIR, HPLC, GC-MS, LC-MS\/MS, DSC und NMR<\/strong>.<\/span><\/p><p><span style=\"color: #000000;\">Als Nano-Test liefern wir nicht nur ein Analyseergebnis, sondern einen vollst\u00e4ndigen <strong>GLP-Konformit\u00e4tsbericht<\/strong>, der die Datenintegrit\u00e4t (ALCOA+-Prinzipien) gew\u00e4hrleistet, \u00fcber einen Pr\u00fcfpfad (Audit Trail) verf\u00fcgt und von internationalen Beh\u00f6rden anerkannt ist. Verifizieren Sie Ihre Produktidentit\u00e4t entlang Ihrer gesamten Lieferkette \u2013 von der Rohstoff-Eingangskontrolle bis hin zu den Freigabetests f\u00fcr das Endprodukt \u2013 mit der Nano-Test-Garantie.<\/span><\/p><\/div><h3><span style=\"color: #000000;\">Why nano test?<\/span><\/h3><ul><li><span style=\"color: #000000;\"><strong>Schnelle R\u00fcckmeldung:<\/strong> Durch automatische Probenvorbereitungssysteme werden die Standard-Analysezeiten verk\u00fcrzt.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Kompetentes Team:<\/strong> Chemiker und Apotheker mit \u00fcber 15 Jahren Erfahrung in der pharmazeutischen Analytik.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Beherrschung der Vorschriften:<\/strong> Vollst\u00e4ndige Konformit\u00e4t mit den aktuellen ICH-, USP-, EP- und FDA-Richtlinien.<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Ergebnis --><\/span><\/p><h2><span style=\"color: #000000;\">Result<\/span><\/h2><p><span style=\"color: #000000;\">Die Sicherheit eines pharmazeutischen Produkts beginnt mit seiner korrekten Identifizierung. <strong>GLP-konforme pharmazeutische Identit\u00e4tspr\u00fcfungen<\/strong> liefern den wissenschaftlichen Nachweis, dass es sich bei dem Produkt um das in der Formulierung angegebene Molek\u00fcl handelt. Eine fehlerhafte Identifizierung kann zu R\u00fcckrufkosten in Millionenh\u00f6he f\u00fchren und die Gesundheit der Patienten gef\u00e4hrden. In einer Zeit, in der die Vorschriften von Tag zu Tag strenger werden, ist die Zusammenarbeit mit einem zuverl\u00e4ssigen und vollst\u00e4ndig GLP-konformen Partner wie Nano-Test der sinnvollste Weg, um den Ruf Ihrer Marke und die \u00f6ffentliche Gesundheit zu sch\u00fctzen.<\/span><\/p><p><span style=\"color: #000000;\"><!-- Ende des Blogbeitrags --><\/span><\/p><p>\u00a0<\/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>GLP-Identit\u00e4tspr\u00fcfungen (Identity Tests) und Nano-Test-L\u00f6sungen f\u00fcr pharmazeutische Produkte In der pharmazeutischen Industrie sind Patientensicherheit und Produktqualit\u00e4t zweifellos die beiden wichtigsten Faktoren. Ein Arzneimittel muss vor der Markteinf\u00fchrung und in jeder Phase des Herstellungsprozesses \u00fcberpr\u00fcft werden. Genau an dieser Stelle kommen die GLP-Identit\u00e4tspr\u00fcfungen f\u00fcr pharmazeutische Produkte (Identity Tests) ins Spiel. Die Gute Laborpraxis (Good Laboratory Practice \u2026 <a href=\"https:\/\/nano-test.de\/en\/2026\/08\/26\/in-vivo-pruefungen-an-medizinprodukten-biokompatibilitaet\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>In-vivo-Tests an Medizinprodukten: Biokompatibilit\u00e4t\u201c&gt;Continue reading <span class=\"screen-reader-text\">In-Vivo Tests on Medical Devices: Biocompatibility<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":4457,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4453","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medizinprodukt-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>In-vivo-Tests an Medizinprodukten: Biokompatibilit\u00e4t | 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