{"id":2232,"date":"2025-06-23T14:09:37","date_gmt":"2025-06-23T14:09:37","guid":{"rendered":"https:\/\/nano-test.de\/?p=2232"},"modified":"2025-07-01T10:22:41","modified_gmt":"2025-07-01T10:22:41","slug":"physikalisch-chemische-prufungen-in-pharmazeutischen","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2025\/06\/23\/physikalisch-chemische-prufungen-in-pharmazeutischen\/","title":{"rendered":"Physicochemical Testing in Pharmaceutical"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"2232\" class=\"elementor elementor-2232\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5a6f2af3 ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5a6f2af3\" 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-6f7ba71a ts-bg-color-over-image\" data-id=\"6f7ba71a\" 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-6ac46c87 elementor-widget elementor-widget-text-editor\" data-id=\"6ac46c87\" 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<h2><span style=\"color: #000000;\">Physicochemical tests for pharmaceutical products within the framework of GLP<\/span><\/h2><p><span style=\"color: #000000;\">Angesichts der Auswirkungen pharmazeutischer Produkte auf die menschliche Gesundheit ist eine sorgf\u00e4ltige Pr\u00fcfung dieser Produkte hinsichtlich ihrer Qualit\u00e4t und Sicherheit unerl\u00e4sslich. Physikalisch-chemische Tests, die im Rahmen der Guten Laborpraxis (<a href=\"https:\/\/nano-test.de\/en\/service\/gute-laborpraxis-glp\/\">GLP<\/a>) durchgef\u00fchrt werden, best\u00e4tigen anhand wissenschaftlicher Daten die \u00dcbereinstimmung pharmazeutischer Produkte mit wichtigen Kriterien wie Identit\u00e4t, Reinheit, Feuchtigkeitsgehalt und mikrobiologischer Reinheit. In unserem GLP-akkreditierten Labor bieten wir unseren Kunden zuverl\u00e4ssige Analysedienstleistungen mit Tests, die gem\u00e4\u00df den Monografien der Ph. Eur. (Europ\u00e4isches Arzneibuch) und USP (Amerikanisches Arzneibuch) durchgef\u00fchrt werden.<\/span><\/p><h2><span style=\"color: #000000;\">The role of physicochemical tests in GLP<\/span><\/h2><p><span style=\"color: #000000;\">GLP standards govern the planning, execution, traceability and reporting of tests, thus increasing the reliability of results. This allows manufacturers to carry out quality control of their pharmaceutical products according to international standards and ensure compliance.<\/span><\/p><h3><span style=\"color: #000000;\">The most important physicochemical tests we carry out as part of GLP<\/span><\/h3><h4><span style=\"color: #000000;\">\u2022 Identification tests<\/span><\/h4><p><span style=\"color: #000000;\">Um zu best\u00e4tigen, dass es sich bei einem <a style=\"color: #000000;\" href=\"https:\/\/nano-test.de\/en\/research\/pharmazeutische-produktprufungen\/\">Arzneimittelwirkstoff<\/a> oder einer Formulierung um den richtigen Stoff handelt, werden verschiedene physikalische und chemische Methoden angewendet. Dazu geh\u00f6ren:<\/span><\/p><ul><li><span style=\"color: #000000;\">Spectroscopic methods (IR, UV, NMR)<\/span><\/li><li><span style=\"color: #000000;\">Chromatographic methods (HPLC, GC)<\/span><\/li><li><span style=\"color: #000000;\">Chemical reaction tests.<\/span><\/li><\/ul><p><span style=\"color: #000000;\">These tests ensure that the product has the identity indicated on the label. (Ph. Eur., USP)<\/span><\/p><h4><span style=\"color: #000000;\">\u2022 Purity tests<\/span><\/h4><p><span style=\"color: #000000;\">These tests are performed to detect potential contaminants of the active ingredient or formulation. These tests detect undesirable substances such as<\/span><\/p><ul><li><span style=\"color: #000000;\">Solvent residues<\/span><\/li><li><span style=\"color: #000000;\">Reaction residues<\/span><\/li><li><span style=\"color: #000000;\">Decomposition products<\/span><\/li><\/ul><p><span style=\"color: #000000;\">They are carried out using limit value tests or quantitative analysis methods. (Ph. Eur., USP)<\/span><\/p><h4><span style=\"color: #000000;\">\u2022 Determination of water content<\/span><\/h4><p><span style=\"color: #000000;\">The moisture content has a direct impact on the shelf life and stability of many pharmaceutical products.<\/span><\/p><ul><li><span style=\"color: #000000;\">Die g\u00e4ngigste Methode, die <b>Karl Fischer Titration<\/b>, wird verwendet, um den Wassergehalt im Produkt genau zu bestimmen. (Ph. Eur., USP)<\/span><\/li><\/ul><h4><span style=\"color: #000000;\">\u2022 Sterility test<\/span><\/h4><p><span style=\"color: #000000;\">Bei <a href=\"https:\/\/nano-test.de\/en\/service\/pharma\/\">pharmazeutischen<\/a> Produkten, die steril sein m\u00fcssen (Injektionsl\u00f6sungen, Augentropfen usw.), wird festgestellt, ob lebende Mikroorganismen vorhanden sind.<\/span><\/p><ul><li><span style=\"color: #000000;\"><a href=\"https:\/\/nano-test.de\/en\/research\/sterilitatstest\/\">Sterilit\u00e4tstests<\/a> werden unter aseptischen Bedingungen durchgef\u00fchrt.<\/span><\/li><li><span style=\"color: #000000;\">They are carried out in accordance with ISO 11737-2 and the pharmacopoeia references. (Ph. Eur., USP)<\/span><\/li><\/ul><h4><span style=\"color: #000000;\">\u2022 Bacterial endotoxin test<\/span><\/h4><p><span style=\"color: #000000;\">This test is critical for parenteral products and certain medical devices:<\/span><\/p><ul><li><span style=\"color: #000000;\">It detects pyrogenic bacterial endotoxins.<\/span><\/li><li><span style=\"color: #000000;\">It is performed using the Limulus-Amoebocyte-Lysate method. This test ensures that the products do not contain any substances that can cause fever after injection. (Ph. Eur., USP)<\/span><\/li><\/ul>\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>Physikalisch-chemische Tests f\u00fcr pharmazeutische Produkte im Rahmen der GLP Angesichts der Auswirkungen pharmazeutischer Produkte auf die menschliche Gesundheit ist eine sorgf\u00e4ltige Pr\u00fcfung dieser Produkte hinsichtlich ihrer Qualit\u00e4t und Sicherheit unerl\u00e4sslich. Physikalisch-chemische Tests, die im Rahmen der Guten Laborpraxis (GLP) durchgef\u00fchrt werden, best\u00e4tigen anhand wissenschaftlicher Daten die \u00dcbereinstimmung pharmazeutischer Produkte mit wichtigen Kriterien wie Identit\u00e4t, Reinheit, \u2026 <a href=\"https:\/\/nano-test.de\/en\/2025\/06\/23\/physikalisch-chemische-prufungen-in-pharmazeutischen\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Physikalisch-chemische Pr\u00fcfungen in pharmazeutischen\u201c&gt;Continue reading <span class=\"screen-reader-text\">Physicochemical Testing in Pharmaceutical<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":2234,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-2232","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-glp-blog"],"yoast_head":"<!-- This site is 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