{"id":8702,"date":"2026-02-17T22:28:44","date_gmt":"2026-02-17T22:28:44","guid":{"rendered":"https:\/\/ovalab.cz\/glossary\/stability-testing-ich-guidelines\/"},"modified":"2026-02-18T00:04:14","modified_gmt":"2026-02-18T00:04:14","slug":"stability-testing-ich-guidelines","status":"publish","type":"glossary","link":"https:\/\/ovalab.cz\/en\/glossary\/stability-testing-ich-guidelines\/","title":{"rendered":"Stability Testing (ICH Guidelines)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8702\" class=\"elementor elementor-8702\" data-elementor-post-type=\"glossary\">\n\t\t\t\t<div class=\"elementor-element elementor-element-s0fv6yf6 e-con-boxed e-flex e-con e-parent \" data-id=\"s0fv6yf6\" data-element_type=\"container\" data-e-type=\"container\">\t\t\t<div class=\"e-con-inner\">\r\n\t\t\t\t<div class=\"elementor-element elementor-element-apl1hspc elementor-widget elementor-widget-text-editor\" data-id=\"apl1hspc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong>Stability testing<\/strong> evaluates how the quality of a drug substance or drug product changes over time under the influence of temperature, humidity, and light. The primary guideline is <a href=\"https:\/\/database.ich.org\/sites\/default\/files\/Q1A%28R2%29%20Guideline.pdf\">ICH Q1A(R2)<\/a>, finalized in 2003, which defines conditions for long-term, accelerated, and intermediate stability studies. Ovalab provides <a href=\"\/services\/pharmaceutical-producers\/\">GMP-compliant stability testing<\/a> for pharmaceutical manufacturers.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-yoeim4l2 elementor-widget elementor-widget-heading\" data-id=\"yoeim4l2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Key Facts About Stability Testing<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ysvj3b2j elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ysvj3b2j\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5eghrm4 elementor-widget elementor-widget-text-editor\" data-id=\"b5eghrm4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li><strong>ICH Q1A(R2):<\/strong> &#8220;Stability Testing of New Drug Substances and Products&#8221; \u2014 defines storage conditions: long-term (25\u00b0C\/60% RH), accelerated (40\u00b0C\/75% RH), and intermediate (30\u00b0C\/65% RH) for Climatic Zone II (EU).<\/li><li><strong>ICH Q1B:<\/strong> Photostability testing \u2014 evaluates the effect of light exposure on drug substances and products using a confirmed change in appearance or degradation.<\/li><li><strong>ICH Q1E:<\/strong> Evaluation of stability data \u2014 provides guidance on statistical methods for shelf-life estimation from stability study results.<\/li><li><strong>Study duration:<\/strong> Long-term studies: 12 months minimum at submission, 24\u201336 months for full shelf-life. Accelerated: 6 months. Testing intervals: 0, 3, 6, 9, 12, 18, 24, 36 months.<\/li><li><strong>Parameters tested:<\/strong> Assay, degradation products, dissolution, water content, microbiological quality, and appearance \u2014 per the relevant <a href=\"\/glossary\/pharmacopoeia-ph-eur\/\">Ph. Eur.<\/a> monograph.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-yqel1cfd elementor-widget elementor-widget-heading\" data-id=\"yqel1cfd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Testing Methods at Ovalab<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2mnzdhkj elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"2mnzdhkj\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-de6wk5y2 elementor-widget elementor-widget-text-editor\" data-id=\"de6wk5y2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Ovalab performs <strong>stability-indicating analytical testing<\/strong> including assay, related substances\/degradation products, <a href=\"\/glossary\/dissolution-testing\/\">dissolution<\/a>, water content, and microbiological examination. Methods are validated per ICH Q2(R1) and executed under <a href=\"\/glossary\/gmp-good-manufacturing-practice\/\">GMP certification<\/a> (S\u00daKL 74726\/2023) and <a href=\"\/glossary\/iso-iec-17025\/\">ISO\/IEC 17025:2017 accreditation<\/a> (\u010cIA 537\/2025). Results support marketing authorization applications and ongoing shelf-life confirmation.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37dnd3al elementor-widget elementor-widget-heading\" data-id=\"37dnd3al\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Frequently Asked Questions<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed0sybuc elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ed0sybuc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-wrv5dm1p faq-green elementor-widget elementor-widget-n-accordion\" data-id=\"wrv5dm1p\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1480\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-1480\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is the purpose of stability testing? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1480\" class=\"elementor-element elementor-element-faq1c e-con-full e-flex e-con e-child \" data-id=\"faq1c\" data-element_type=\"container\" data-e-type=\"container\">\t\t<div class=\"elementor-element elementor-element-ddpizk9o elementor-widget elementor-widget-text-editor\" data-id=\"ddpizk9o\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Stability testing determines the shelf life (expiry date) and storage conditions of pharmaceutical products. It demonstrates that the drug remains within specifications throughout its intended storage period, as required for marketing authorization.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\r\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1481\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1481\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What are the ICH stability storage conditions for the EU? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1481\" class=\"elementor-element elementor-element-faq2c e-con-full e-flex e-con e-child \" data-id=\"faq2c\" data-element_type=\"container\" data-e-type=\"container\">\t\t<div class=\"elementor-element elementor-element-uz9bp7cx elementor-widget elementor-widget-text-editor\" data-id=\"uz9bp7cx\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>For Climatic Zone II (EU): Long-term: 25\u00b0C \u00b1 2\u00b0C \/ 60% RH \u00b1 5% RH. Accelerated: 40\u00b0C \u00b1 2\u00b0C \/ 75% RH \u00b1 5% RH. Intermediate (if needed): 30\u00b0C \u00b1 2\u00b0C \/ 65% RH \u00b1 5% RH.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\r\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1482\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1482\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is a stability-indicating method? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1482\" class=\"elementor-element elementor-element-faq3c e-con-full e-flex e-con e-child \" data-id=\"faq3c\" data-element_type=\"container\" data-e-type=\"container\">\t\t<div class=\"elementor-element elementor-element-z1xo09j2 elementor-widget elementor-widget-text-editor\" data-id=\"z1xo09j2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>A stability-indicating analytical method can distinguish the active ingredient from its degradation products. It is validated to demonstrate specificity, ensuring accurate measurement of API content even in the presence of degradants.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\r\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1483\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1483\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How long does a stability study take? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1483\" class=\"elementor-element elementor-element-faq4c e-con-full e-flex e-con e-child \" data-id=\"faq4c\" data-element_type=\"container\" data-e-type=\"container\">\t\t<div class=\"elementor-element elementor-element-b1hejv52 elementor-widget elementor-widget-text-editor\" data-id=\"b1hejv52\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Long-term studies require a minimum of 12 months data at the time of regulatory submission, with commitments to continue to the proposed shelf life (typically 24\u201336 months). Accelerated studies run for 6 months.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\r\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1484\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1484\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Can Ovalab perform photostability testing? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1484\" class=\"elementor-element elementor-element-faq5c e-con-full e-flex e-con e-child \" data-id=\"faq5c\" data-element_type=\"container\" data-e-type=\"container\">\t\t<div class=\"elementor-element elementor-element-jtr1p8rb elementor-widget elementor-widget-text-editor\" data-id=\"jtr1p8rb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Yes. Ovalab conducts photostability studies per ICH Q1B guidelines, exposing samples to defined light conditions and testing for changes in appearance, assay, and degradation products.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\r\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What is the purpose of stability testing?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Stability testing determines the shelf life (expiry date) and storage conditions of pharmaceutical products. 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Ovalab conducts photostability studies per ICH Q1B guidelines, exposing samples to defined light conditions and testing for changes in appearance, assay, and degradation products.\"}}]}<\/script>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-wodu4ihf elementor-align-left elementor-widget elementor-widget-button\" data-id=\"wodu4ihf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/ovalab.cz\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request Analysis<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\r\n\t\t\t\t<\/div>\r\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"","protected":false},"featured_media":0,"template":"","meta":{"_seowing_meta_title":"Stability Testing (ICH Guidelines) \u2014 Pharmaceutical Shelf Life | Ovalab","_seowing_meta_description":"Stability testing per ICH Q1A(R2) determines pharmaceutical shelf life. Ovalab provides accredited long-term, accelerated, and stress testing under GMP.","_seowing_focus_keyword":"stability testing","_seowing_canonical_url":"","_seowing_robots":"","_seowing_robots_noindex":false,"_seowing_robots_nofollow":false,"_seowing_seo_score":0},"glossary_category":[],"class_list":["post-8702","glossary","type-glossary","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ovalab.cz\/en\/wp-json\/wp\/v2\/glossary\/8702","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ovalab.cz\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/ovalab.cz\/en\/wp-json\/wp\/v2\/types\/glossary"}],"version-history":[{"count":1,"href":"https:\/\/ovalab.cz\/en\/wp-json\/wp\/v2\/glossary\/8702\/revisions"}],"predecessor-version":[{"id":8724,"href":"https:\/\/ovalab.cz\/en\/wp-json\/wp\/v2\/glossary\/8702\/revisions\/8724"}],"wp:attachment":[{"href":"https:\/\/ovalab.cz\/en\/wp-json\/wp\/v2\/media?parent=8702"}],"wp:term":[{"taxonomy":"glossary_category","embeddable":true,"href":"https:\/\/ovalab.cz\/en\/wp-json\/wp\/v2\/glossary_category?post=8702"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}