{"id":4530,"date":"2026-09-30T20:16:08","date_gmt":"2026-09-30T20:16:08","guid":{"rendered":"https:\/\/nano-test.de\/?p=4530"},"modified":"2026-09-30T20:16:52","modified_gmt":"2026-09-30T20:16:52","slug":"bestimmung-des-wassergehalts-in-pharmazeutischen-produkten","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2026\/09\/30\/bestimmung-des-wassergehalts-in-pharmazeutischen-produkten\/","title":{"rendered":"Determination of the water content in pharmaceutical products"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4530\" class=\"elementor elementor-4530\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3b8f5ace ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3b8f5ace\" 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-5aa5e858 ts-bg-color-over-image\" data-id=\"5aa5e858\" 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-21ccec76 elementor-widget elementor-widget-text-editor\" data-id=\"21ccec76\" 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;\">Determination of the water content in pharmaceutical products according to GLP: Karl Fischer and Drying Loss Methods<\/span><\/h2><p><span style=\"color: #000000;\">Der Wassergehalt in pharmazeutischen Produkten ist ein Parameter, der die Stabilit\u00e4t, Haltbarkeit und Wirksamkeit des Produkts unmittelbar beeinflusst. Der Feuchtigkeitsgehalt eines Arzneimittels beeinflusst die Geschwindigkeit des chemischen Abbaus, das Risiko mikrobiellen Wachstums sowie physikalische Eigenschaften wie die Flie\u00dfeigenschaften und die Tablettenh\u00e4rte. Daher ist die <strong>GLP-konforme Wasserbestimmung in pharmazeutischen Produkten<\/strong> ein unverzichtbarer Bestandteil der Qualit\u00e4tskontrolle.<\/span><\/p><p><span style=\"color: #000000;\">The water determination carried out as part of the good laboratory practice (GLP) ensures that the results are reliable, traceable and acceptable for international supervisory authorities. In this article, we will cover the importance of determining the water content in pharmaceutical products, the basic methods used, and the GLP-compliant Nano-Test services in this area.<\/span><\/p><h2><span style=\"color: #000000;\">The importance of water content in pharmaceutical products<\/span><\/h2><p><span style=\"color: #000000;\">Water in pharmaceutical products can be both a desirable and undesirable ingredient. Some active ingredients are in hydrated form, with water molecules being an integral part of the crystal structure. However, free water (adsorbed moisture) usually poses a risk of product stability [quote:6].<\/span><\/p><p><span style=\"color: #000000;\">The main reasons for controlling the water content:<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Chemische Stabilit\u00e4t:<\/strong> Hydrolyseempfindliche Wirkstoffe (z. B. Aspirin, Penicilline) zersetzen sich in Gegenwart von Feuchtigkeit schnell.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Mikrobiologische Sicherheit:<\/strong> Eine hohe Wasseraktivit\u00e4t f\u00f6rdert das Wachstum von Bakterien und Schimmelpilzen. ICH Q6A kn\u00fcpft die Notwendigkeit mikrobiologischer Grenzwertpr\u00fcfungen an den \u201eTrockenheitsgrad\u201c des Produkts [Zitat:6].<\/span><\/li><li><span style=\"color: #000000;\"><strong>Physikalische Eigenschaften:<\/strong> Feuchtigkeit beeinflusst die Flie\u00dff\u00e4higkeit von Pulver, die Tablettenh\u00e4rte und die Aufl\u00f6sungsgeschwindigkeit [Zitat:12].<\/span><\/li><li><span style=\"color: #000000;\"><strong>Shelf life:<\/strong> Der Wassergehalt bestimmt das Zerfallsprofil des Produkts im Laufe der Zeit.<\/span><\/li><\/ul><h2><span style=\"color: #000000;\">Basic analytical methods for water determination<\/span><\/h2><p><span style=\"color: #000000;\">Three basic methods are used to determine the water content in pharmaceutical products. The choice of method depends on the properties of the substance to be analyzed and the requirements specified in the pharmacopoeia monograph.<\/span><\/p><h3><span style=\"color: #000000;\">1. Karl Fischer Titration<\/span><\/h3><p><span style=\"color: #000000;\">Sie gilt als <strong>Goldstandard<\/strong> f\u00fcr die Wasserbestimmung in pharmazeutischen Produkten. Die Karl-Fischer-Reaktion basiert auf der quantitativen Reaktion von Jod und Schwefeldioxid in Gegenwart von Wasser [Zitat:13].<\/span><\/p><p><span style=\"color: #000000;\">There are two basic variants:<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Volumetrische Karl-Fischer-Methode:<\/strong> Geeignet f\u00fcr Proben mit hohem Wassergehalt (&gt; 0,1 %). Die Wassermenge wird durch Messung des Titrantenvolumens berechnet [Zitat:1].<\/span><\/li><li><span style=\"color: #000000;\"><strong>Kulometrische Karl-Fischer-Methode:<\/strong> Ideal f\u00fcr die Bestimmung von Spurenwasser (&lt; 0,1 %). Die durch Elektrolyse erzeugte Jodmenge wird gemessen [Zitat:4].<\/span><\/li><\/ul><p><span style=\"color: #000000;\">The Karl Fischer method provides the most reliable results as it is specific to water and not affected by other volatile substances [quote:20].<\/span><\/p><h3><span style=\"color: #000000;\">2. Loss of Drying (Loss on Drying - LOD)<\/span><\/h3><p><span style=\"color: #000000;\">In this method, the sample is dried to constant weight at a certain temperature (usually 100-105\u00b0C) and the weight loss is calculated as a percentage [quote:8][quote:14].<\/span><\/p><p><span style=\"color: #000000;\">The drying loss method not only measures water, but also volatile solvents and other volatile components. Therefore, the result can be higher than the actual water content [quote:20].<\/span><\/p><h3><span style=\"color: #000000;\">3. Thermogravimetry (TGA)<\/span><\/h3><p><span style=\"color: #000000;\">Thermogravimetry measures the weight change of the sample under a controlled temperature program. It is an alternative method for substances where the Karl Fischer method is not applicable (due to solubility problems) [Quote:4].<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Act<\/span><\/th><th><span style=\"color: #000000;\">Principle<\/span><\/th><th><span style=\"color: #000000;\">Suitable water area<\/span><\/th><th><span style=\"color: #000000;\">Advantages<\/span><\/th><th><span style=\"color: #000000;\">Limitations<\/span><\/th><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\"><strong>Karl Fischer (volumetric)<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Iodine water reaction, measurement of titrant volume<\/span><\/td><td><span style=\"color: #000000;\">&gt;0.1% (high water content)<\/span><\/td><td><span style=\"color: #000000;\">Especially for water, high accuracy<\/span><\/td><td><span style=\"color: #000000;\">Not applicable to substances with solubility problems<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Karl Fischer Method (Colometric)<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Iodine generation by electrolysis<\/span><\/td><td><span style=\"color: #000000;\">&amp;lt;%0.1 (Trace water)<\/span><\/td><td><span style=\"color: #000000;\">Ultra-low detection limit, small amount of sample<\/span><\/td><td><span style=\"color: #000000;\">Not suitable for high water content<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Drying Loss (LOD)<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Drying to constant weight, weight loss<\/span><\/td><td><span style=\"color: #000000;\">Wide measuring range<\/span><\/td><td><span style=\"color: #000000;\">Simple, inexpensive, widely used in the pharmacopoeia<\/span><\/td><td><span style=\"color: #000000;\">Not water specific, also measures volatile substances<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Thermogravimetry (TGA)<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Weight change at controlled temperature<\/span><\/td><td><span style=\"color: #000000;\">Wide measuring range<\/span><\/td><td><span style=\"color: #000000;\">Alternative to the Karl Fischer method, no resolution problem<\/span><\/td><td><span style=\"color: #000000;\">Not water specific, requires interpretation<\/span><\/td><\/tr><\/tbody><\/table><h2><span style=\"color: #000000;\">Pharmacopoeia Requirements and I-Guidelines<\/span><\/h2><p><span style=\"color: #000000;\">The determination of the water content in drugs is described in detail in the monographs of the pharmacopoeias (Ph. Eur., USP, JP). The Karl Fischer method is recognized by the European Pharmacopoeia (Ph. Eur.) and the US Pharmacopoeia (USP) as a reference method [quote:5][quote:10].<\/span><\/p><p><span style=\"color: #000000;\">The ICH Guideline Q6A provides an orientation framework for setting water content specifications for new active ingredients and drugs [Quote:6]. The guideline points out that the \"dry content\" of the product can be used to determine the need for microbiological limit checks.<\/span><\/p><div class=\"note\"><span style=\"color: #000000;\"><strong>Wichtig:<\/strong> Die Wasserbestimmung in pharmazeutischen Produkten muss in Laboren erfolgen, die den GLP-Grunds\u00e4tzen (Good Laboratory Practice) entsprechen. Andernfalls werden die erzielten Ergebnisse von den Zulassungsbeh\u00f6rden nicht anerkannt.<\/span><\/div><h2><span style=\"color: #000000;\">GLP-compliant water content determination services with Nano-Test<\/span><\/h2><p><span style=\"color: #000000;\">Der Wassergehalt Ihrer pharmazeutischen Produkte ist ein entscheidender Bestandteil sowohl der Qualit\u00e4tskontrolle als auch des Zulassungsverfahrens. <strong>Nano-Test<\/strong> ist mit seinen umfassenden Dienstleistungen zur Wassergehaltsbestimmung in GLP-akkreditierten Laboren ein zuverl\u00e4ssiger L\u00f6sungspartner f\u00fcr die pharmazeutische Industrie [citation:5][citation:9].<\/span><\/p><div class=\"highlight\"><h3><span style=\"color: #000000;\">Nano-Test \u2013 Performance Description<\/span><\/h3><p><span style=\"color: #000000;\">Nano-Test bietet f\u00fcr pharmazeutische Produkte <strong>GLP-konforme Dienstleistungen zur Wassergehaltsbestimmung (Water Content Determination)<\/strong> an. Unser Leistungsportfolio:<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Karl Fischer Titration:<\/strong> Pr\u00e4zise Wasserbestimmung \u00fcber einen breiten Konzentrationsbereich hinweg mittels volumetrischer und coulometrischer Verfahren. Vollst\u00e4ndig konform mit den Monografien der Ph. Eur. und USP [Zitat:5].<\/span><\/li><li><span style=\"color: #000000;\"><strong>Drying Loss (LOD):<\/strong> Bestimmung von Wasser und fl\u00fcchtigen Bestandteilen durch Trocknung bis zum konstanten Gewicht bei den in den Pharmakop\u00f6e-Monografien angegebenen Temperaturen und Zeiten [Zitat:8].<\/span><\/li><li><span style=\"color: #000000;\"><strong>Thermogravimetry (TGA):<\/strong> Alternative L\u00f6sung f\u00fcr Substanzen, bei denen die Karl-Fischer-Methode nicht anwendbar ist [Zitat:4].<\/span><\/li><li><span style=\"color: #000000;\"><strong>Methodenvalidierung:<\/strong> ICH Q2(R2)-konforme, auf Ihre Produktmatrix zugeschnittene Methodenentwicklung und -validierung.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Pharmazeutische Wasseranalysen:<\/strong> Analyse von gereinigtem Wasser (Ph. Eur. 0008), Wasser f\u00fcr Injektionszwecke (Ph. Eur. 0169) und anderen pharmazeutischen Wasserqualit\u00e4ten [Zitat:16].<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Alle unsere Analysen werden in Form von <strong>GLP-Konformit\u00e4tsberichten<\/strong> vorgelegt, die \u00fcber eine Inspektionsgenehmigung verf\u00fcgen und die Datenintegrit\u00e4t (ALCOA+-Prinzipien) gew\u00e4hrleisten.<\/span><\/p><\/div><h3><span style=\"color: #000000;\">Advantages of Nano-Test in determining the water content:<\/span><\/h3><ul><li><span style=\"color: #000000;\"><strong>GLP-Akkreditierung:<\/strong> Laborinfrastruktur mit OECD-GLP-Konformit\u00e4tserkl\u00e4rung [Zitat:9][Zitat:15].<\/span><\/li><li><span style=\"color: #000000;\"><strong>Kompetenz in zwei Methoden:<\/strong> Sowohl volumetrische als auch coulometrische Karl-Fischer-Titratoren.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Pharmakop\u00f6e-Konformit\u00e4t:<\/strong> Testprotokolle, die vollst\u00e4ndig mit den Monografien von Ph. Eur., USP und JP konform sind.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Schnelle Berichterstellung:<\/strong> Ergebnislieferung innerhalb von 3\u20135 Werktagen bei Standard-Wasserbestimmungsanalysen.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Fachkompetentes Team:<\/strong> Ein Team aus Chemikern mit Erfahrung in der pharmazeutischen Analyse und Validierung.<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Determining the water content in pharmaceutical products is a crucial quality parameter for the stability, safety and effectiveness of the product. While the Karl Fischer titration continues to be the reference method due to its specific structure and high accuracy, drying loss and thermogravimetry offer alternative solutions in certain cases.<\/span><\/p><p><span style=\"color: #000000;\">With its GLP-accredited laboratories, its advanced analytical infrastructure and its specialist staff, NANO-TEST comprehensively meets the requirements of pharmaceutical manufacturers for water content determination. Collaborate with Nano-Test to increase the quality of your products and accelerate their market launch.<\/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>Bestimmung des Wassergehalts in pharmazeutischen Produkten nach GLP: Karl-Fischer- und Trocknungsverlustverfahren Der Wassergehalt in pharmazeutischen Produkten ist ein Parameter, der die Stabilit\u00e4t, Haltbarkeit und Wirksamkeit des Produkts unmittelbar beeinflusst. Der Feuchtigkeitsgehalt eines Arzneimittels beeinflusst die Geschwindigkeit des chemischen Abbaus, das Risiko mikrobiellen Wachstums sowie physikalische Eigenschaften wie die Flie\u00dfeigenschaften und die Tablettenh\u00e4rte. Daher ist die \u2026 <a href=\"https:\/\/nano-test.de\/en\/2026\/09\/30\/bestimmung-des-wassergehalts-in-pharmazeutischen-produkten\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Bestimmung des Wassergehalts in pharmazeutischen Produkten\u201c&gt;Continue reading <span class=\"screen-reader-text\">Determination of the water content in pharmaceutical products<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":4531,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":["post-4530","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bestimmung des Wassergehalts in pharmazeutischen Produkten | Nano-Test\u00ae<\/title>\n<meta name=\"description\" content=\"Bestimmung des Wassergehalts in pharmazeutischen Produkten. 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