{"id":4677,"date":"2026-11-10T06:34:21","date_gmt":"2026-11-10T06:34:21","guid":{"rendered":"https:\/\/nano-test.de\/?p=4677"},"modified":"2026-11-10T06:35:21","modified_gmt":"2026-11-10T06:35:21","slug":"stabilitaetstests-fuer-kosmetika-glp-konforme-analysen","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2026\/11\/10\/stabilitaetstests-fuer-kosmetika-glp-konforme-analysen\/","title":{"rendered":"Stability testing for cosmetics | GLP-compliant analyses"},"content":{"rendered":"<h1><span style=\"color: #000000;\">Stability Tests on Cosmetic Products: Determination of Quality and Durability<\/span><\/h1>\n<p><span style=\"color: #000000;\">Ein <a href=\"https:\/\/nano-test.de\/en\/service\/kosmetik\/\">Kosmetikprodukt<\/a> muss w\u00e4hrend seiner gesamten Haltbarkeitsdauer das Aussehen, den Geruch, die Konsistenz und die Wirksamkeit des ersten Tages beibehalten k\u00f6nnen. Allerdings sind Formulierungen empfindlich gegen\u00fcber Umweltfaktoren wie Temperaturschwankungen, Lichteinwirkung, Feuchtigkeitsschwankungen und Wechselwirkungen mit der Verpackung. Mit der Zeit auftretende Phasentrennung, Farbver\u00e4nderungen, Geruchsver\u00e4nderungen oder der Verlust der Wirksamkeit des Konservierungssystems gef\u00e4hrden sowohl den kommerziellen Wert des Produkts als auch die Verbrauchersicherheit. Daher ist der <strong>Kosmetik-Stabilit\u00e4tstest<\/strong> ein unverzichtbarer Bestandteil des Produktentwicklungsprozesses und des Zulassungsdossiers.<\/span><\/p>\n<p><span style=\"color: #000000;\">Die grundlegende Richtlinie, die international als Referenz f\u00fcr die Stabilit\u00e4tsbewertung herangezogen wird, ist <strong>ISO\/TR 18811<\/strong>. Dieser technische Bericht bietet einen umfassenden Rahmen f\u00fcr die Konzeption, Durchf\u00fchrung und Auswertung von Stabilit\u00e4tspr\u00fcfungen f\u00fcr Kosmetikprodukte. Dar\u00fcber hinaus schreiben die im Rahmen der EU-Kosmetikverordnung (EG) Nr. 1223\/2009 erstellte Produktinformationsdatei (PIF) und der Sicherheitsbewertungsbericht (SAR) Stabilit\u00e4tsdaten zwingend vor.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Why are stability tests required?<\/span><\/h2>\n<p><span style=\"color: #000000;\">Cosmetic stability tests are performed to demonstrate that the product meets acceptable quality criteria during its set shelf life. These exams provide answers to the following questions:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Physikalische Stabilit\u00e4t:<\/strong> Kommt es im Produkt im Laufe der Zeit zu Phasentrennung, Ausf\u00e4llung, Viskosit\u00e4ts\u00e4nderungen oder Kristallisation?<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Chemische Stabilit\u00e4t:<\/strong> Zerfallen Wirkstoffe, Konservierungsmittel oder Farbpigmente? \u00c4ndert sich der pH-Wert?<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Mikrobiologische Stabilit\u00e4t:<\/strong> Beh\u00e4lt das Konservierungssystem seine Wirksamkeit \u00fcber die gesamte Haltbarkeitsdauer bei?<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Vertr\u00e4glichkeit mit der Verpackung:<\/strong> Kommt es zu Reaktionen oder zur Migration zwischen dem Produkt und dem Verpackungsmaterial?<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">Answering these questions with scientific methods ensures both the safe marketing of the product and the avoidance of possible recall risks.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Types of Stability Tests and Application Conditions<\/span><\/h2>\n<p><span style=\"color: #000000;\">In line with industry applications, three basic types of stability tests are used for cosmetic products:<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">1. Long-term stability test (real-time)<\/span><\/h3>\n<p><span style=\"color: #000000;\">Detects the behavior of the product over time under normal storage conditions (usually 25 \u00b1 2 \u00b0C, 60 \u00b1 5% R.F.). The test duration is usually 12 to 36 months and serves as a reference for determining the final shelf life of the product.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">2. Accelerated Stability Test<\/span><\/h3>\n<p><span style=\"color: #000000;\">These are tests performed under high temperature conditions (usually 40 \u00b1 2 \u00b0C, 75 \u00b1 5% relative humidity). The aim is to quickly identify potential weaknesses of the formulation without having to wait for the results of long-term tests. The results of the accelerated tests should be evaluated along with the long-term data; They alone are not enough to determine the shelf life.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">3. Cycle test<\/span><\/h3>\n<p><span style=\"color: #000000;\">Simulates the temperature fluctuations that the product may be exposed to during transport and storage. Typically, temperature cycles in the range of -5 \u00b0C to +45 \u00b0C are carried out. This is particularly important to assess the risk of phase separation in emulsion-based products.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- Tabellenanfang --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Comparison of stability test methods<\/span><\/h2>\n<p><span style=\"color: #000000;\">The following table summarizes the stability test methods used in cosmetic products and their essential characteristics:<\/span><\/p>\n<table>\n<thead>\n<tr>\n<th><span style=\"color: #000000;\">Test type<\/span><\/th>\n<th><span style=\"color: #000000;\">Conditions<\/span><\/th>\n<th><span style=\"color: #000000;\">Duration<\/span><\/th>\n<th><span style=\"color: #000000;\">Purpose<\/span><\/th>\n<th><span style=\"color: #000000;\">Evaluated parameters<\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Long-term<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">25 \u00b1 2 \u00b0C \/ 60 \u00b1 5% r. f.<\/span><\/td>\n<td><span style=\"color: #000000;\">12-36 Months<\/span><\/td>\n<td><span style=\"color: #000000;\">Determination of the final shelf life<\/span><\/td>\n<td><span style=\"color: #000000;\">Physical, chemical and microbiological stability<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Accelerated<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">40 \u00b1 2 \u00b0C \/ 75 \u00b1 5% r. f.<\/span><\/td>\n<td><span style=\"color: #000000;\">3-6 Months<\/span><\/td>\n<td><span style=\"color: #000000;\">Quick detection of potential vulnerabilities<\/span><\/td>\n<td><span style=\"color: #000000;\">Degradation products, color changes, pH shift<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Cycle (cycle)<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">Cycles between -5 \u00b0C and +45 \u00b0C<\/span><\/td>\n<td><span style=\"color: #000000;\">1-3 Months<\/span><\/td>\n<td><span style=\"color: #000000;\">Simulation of fluctuations during transport and storage<\/span><\/td>\n<td><span style=\"color: #000000;\">Phase separation, viscosity change, packaging integrity<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Light stability<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">I Q1B compliant light exposure<\/span><\/td>\n<td><span style=\"color: #000000;\">2-4 Weeks<\/span><\/td>\n<td><span style=\"color: #000000;\">Evaluation of light-related decomposition<\/span><\/td>\n<td><span style=\"color: #000000;\">Color change, drug loss, oxidation<\/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 --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Packaging compatibility: an aspect that should not be neglected<\/span><\/h2>\n<p><span style=\"color: #000000;\">The stability test should include not only the formulation itself, but also the interaction of the product with the packaging. Various types of packaging, such as glass, plastic, metal or airtight pumps, can cause the product to behave differently in terms of moisture loss, oxidation, translucency and chemical migration.<\/span><\/p>\n<p><span style=\"color: #000000;\">ISO\/TR 18811 recommends carrying out stability tests in the final trade packaging (or equivalent packaging). Phenomena such as migration from the packaging (e.g. the transition from plasticizers to the product) or adsorption (attaching the active ingredient to the packaging surface) can directly impair the safety and effectiveness of the product.<\/span><\/p>\n<div class=\"note\"><span style=\"color: #000000;\"><strong>Wichtig:<\/strong> Die Ergebnisse der Stabilit\u00e4tspr\u00fcfungen gelten ausschlie\u00dflich f\u00fcr den getesteten Verpackungstyp und die getestete Formulierung. Bei einer \u00c4nderung des Verpackungslieferanten, der Formulierung oder des Produktionsstandorts kann eine Neubewertung der Stabilit\u00e4tsstudien erforderlich sein.<\/span><\/div>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Nano-Test --><\/span><\/p>\n<h2><span style=\"color: #000000;\">GLP compliant stability tests for cosmetics with nano-test<\/span><\/h2>\n<p><span style=\"color: #000000;\">Die Haltbarkeit und Qualit\u00e4tssicherung Ihrer Kosmetikprodukte beruhen auf korrekt konzipierten und sorgf\u00e4ltig durchgef\u00fchrten Stabilit\u00e4tsstudien. <strong>Nano-Test<\/strong> ist mit seinen umfassenden Stabilit\u00e4tspr\u00fcfungsdienstleistungen, die sich an den einschl\u00e4gigen Normen orientieren, ein zuverl\u00e4ssiger L\u00f6sungspartner f\u00fcr die Kosmetikbranche.<\/span><\/p>\n<div class=\"highlight\">\n<h3><span style=\"color: #000000;\">Description of Nano-Test Services<\/span><\/h3>\n<p><span style=\"color: #000000;\">Nano-Test bietet <strong>Stabilit\u00e4tstests (Stability Test)<\/strong> f\u00fcr Kosmetikprodukte an.<\/span><\/p>\n<p><span style=\"color: #000000;\">Our service portfolio:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Langzeitstabilit\u00e4t:<\/strong> 12\u201336-monatige \u00dcberwachung, regelm\u00e4\u00dfige Probenahme und Analyse unter Bedingungen von 25 \u00b0C\/60 % r. F.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Beschleunigte Stabilit\u00e4tspr\u00fcfung:<\/strong> 3\u20136-monatige Untersuchungen unter Bedingungen von 40 \u00b0C und 75 % r. F. zur fr\u00fchzeitigen Erkennung von Schwachstellen in der Rezeptur.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Zyklustests:<\/strong> Temperaturzyklen, die Transport- und Lagerbedingungen simulieren.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Light stability:<\/strong> ICH Q1B-konforme Lichtbest\u00e4ndigkeitstests.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Vertr\u00e4glichkeit mit der Verpackung:<\/strong> Bewertung der Wechselwirkungen zwischen Produkt und Verpackung (Migration, Adsorption).<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Physikalisch-chemische Analysen:<\/strong> pH-Wert, Viskosit\u00e4t, Farbe (L*a*b*), Phasentrennung, Wirkstoffbestimmung und mikrobiologische Qualit\u00e4t.<\/span><\/li>\n<\/ul>\n<div>\n<p><span style=\"color: #000000;\">Contact us. info@nano-test.de<\/span><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Stabilit\u00e4tstests bei Kosmetikprodukten: Bestimmung von Qualit\u00e4t und Haltbarkeit Ein Kosmetikprodukt muss w\u00e4hrend seiner gesamten Haltbarkeitsdauer das Aussehen, den Geruch, die Konsistenz und die Wirksamkeit des ersten Tages beibehalten k\u00f6nnen. Allerdings sind Formulierungen empfindlich gegen\u00fcber Umweltfaktoren wie Temperaturschwankungen, Lichteinwirkung, Feuchtigkeitsschwankungen und Wechselwirkungen mit der Verpackung. Mit der Zeit auftretende Phasentrennung, Farbver\u00e4nderungen, Geruchsver\u00e4nderungen oder der Verlust der \u2026 <a href=\"https:\/\/nano-test.de\/en\/2026\/11\/10\/stabilitaetstests-fuer-kosmetika-glp-konforme-analysen\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Stabilit\u00e4tstests f\u00fcr Kosmetika | GLP-konforme Analysen\u201c&gt;Continue reading <span class=\"screen-reader-text\">Stability testing for cosmetics | GLP-compliant analyses<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":4678,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[],"class_list":["post-4677","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-kozmetik-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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