{"id":3788,"date":"2022-12-21T09:54:23","date_gmt":"2022-12-21T07:54:23","guid":{"rendered":"https:\/\/hhac.de\/services\/stability-testing\/"},"modified":"2026-07-31T12:36:51","modified_gmt":"2026-07-31T10:36:51","slug":"stability-testing","status":"publish","type":"page","link":"https:\/\/hhac.de\/en\/services\/stability-testing\/","title":{"rendered":"Stability testing"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-cd32ci-8d35f98ad2ab3f2c79c8107a76a04f7e\">\n.avia-section.av-cd32ci-8d35f98ad2ab3f2c79c8107a76a04f7e{\nbackground-color:#ffffff;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-cd32ci-8d35f98ad2ab3f2c79c8107a76a04f7e main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_heading  avia-builder-el-first  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-3788'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-sjnps2-e587056f2e3489f172db89a34f40503b\">\n.flex_column.av-sjnps2-e587056f2e3489f172db89a34f40503b{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-sjnps2-e587056f2e3489f172db89a34f40503b av_one_half  avia-builder-el-1  el_before_av_one_half  avia-builder-el-first  first av-break-at-tablet flex_column_div av-zero-column-padding '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-qq13rm-8f4619ee33eddbf5296f7084331fd268\">\n.avia-image-container.av-qq13rm-8f4619ee33eddbf5296f7084331fd268 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-qq13rm-8f4619ee33eddbf5296f7084331fd268 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-qq13rm-8f4619ee33eddbf5296f7084331fd268 av-styling- avia-align-left  avia-builder-el-2  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" class='wp-image-3049 avia-img-lazy-loading-not-3049 avia_image ' src=\"https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-02-hhac-labor-dr-heusler.jpg\" alt='' title=''  height=\"1417\" width=\"1751\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-02-hhac-labor-dr-heusler.jpg 1751w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-02-hhac-labor-dr-heusler-300x243.jpg 300w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-02-hhac-labor-dr-heusler-1030x834.jpg 1030w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-02-hhac-labor-dr-heusler-768x622.jpg 768w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-02-hhac-labor-dr-heusler-1536x1243.jpg 1536w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-02-hhac-labor-dr-heusler-1500x1214.jpg 1500w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-02-hhac-labor-dr-heusler-495x400.jpg 495w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-02-hhac-labor-dr-heusler-845x684.jpg 845w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-02-hhac-labor-dr-heusler-705x571.jpg 705w\" sizes=\"(max-width: 1751px) 100vw, 1751px\" \/><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-pgcq8i-f23bc08babd9e660992ecce5d2198b32\">\n.flex_column.av-pgcq8i-f23bc08babd9e660992ecce5d2198b32{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-pgcq8i-f23bc08babd9e660992ecce5d2198b32 av_one_half  avia-builder-el-3  el_after_av_one_half  el_before_av_one_full  av-break-at-tablet flex_column_div av-zero-column-padding '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-59t90i-eb76997bb8c104222b760e5bddf4a124\">\n#top .av_textblock_section.av-59t90i-eb76997bb8c104222b760e5bddf4a124 .avia_textblock{\ncolor:#b8b9bb;\n}\n<\/style>\n<section  class='av_textblock_section av-59t90i-eb76997bb8c104222b760e5bddf4a124'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><h3>BRIEFLY EXPLAINED<\/h3>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4c5m6q-3024763acc9162e2e9015ef6196b65c4\">\n#top .hr.hr-invisible.av-4c5m6q-3024763acc9162e2e9015ef6196b65c4{\nmargin-top:-50px;\nheight:1px;\n}\n<\/style>\n<div  class='hr av-4c5m6q-3024763acc9162e2e9015ef6196b65c4 hr-invisible  avia-builder-el-5  el_after_av_textblock  el_before_av_heading '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2yia1u-721701bbd70caccd94e592eb4ddc13f7\">\n#top .av-special-heading.av-2yia1u-721701bbd70caccd94e592eb4ddc13f7{\npadding-bottom:30px;\nfont-size:50px;\n}\nbody .av-special-heading.av-2yia1u-721701bbd70caccd94e592eb4ddc13f7 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-2yia1u-721701bbd70caccd94e592eb4ddc13f7 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-2yia1u-721701bbd70caccd94e592eb4ddc13f7 .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-2yia1u-721701bbd70caccd94e592eb4ddc13f7 .av-special-heading-tag{\nfont-size:30px;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-2yia1u-721701bbd70caccd94e592eb4ddc13f7 .av-special-heading-tag{\nfont-size:30px;\n}\n}\n<\/style>\n<div  class='av-special-heading av-2yia1u-721701bbd70caccd94e592eb4ddc13f7 av-special-heading-h1 blockquote modern-quote  avia-builder-el-6  el_after_av_hr  el_before_av_textblock  av-inherit-size'><h1 class='av-special-heading-tag'  itemprop=\"headline\"  >Stability Testing Throughout the Entire Product Life Cycle<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-lbxh4mml-2af424af93e0f4efdd55111b66a59d30'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Product stability is a critical quality attribute. Only valid stability data can demonstrate that a pharmaceutical product, medical device, or cosmetic product continues to meet defined quality requirements throughout its shelf life. HHAC supports you in the planning, execution, and documentation of stability studies in accordance with applicable ICH guidelines. From exploratory studies during development and registration studies to ongoing stability programs, we support our clients throughout the entire product life cycle. Our qualified climatic chambers allow storage under controlled conditions and the performance of all required analytical testing in a GMP-compliant environment.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4p0kuq-ec64bbc0c631bfd48e0a89e14a5a9226\">\n#top .hr.hr-invisible.av-4p0kuq-ec64bbc0c631bfd48e0a89e14a5a9226{\nheight:20px;\n}\n<\/style>\n<div  class='hr av-4p0kuq-ec64bbc0c631bfd48e0a89e14a5a9226 hr-invisible  avia-builder-el-8  el_after_av_textblock  el_before_av_button '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-button-wrap av-izrqrm-56e61eaaccfa9dfa50bb77d19f0380e6-wrap avia-button-left  avia-builder-el-9  el_after_av_hr  avia-builder-el-last '>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-izrqrm-56e61eaaccfa9dfa50bb77d19f0380e6\">\n#top #wrap_all .avia-button.av-izrqrm-56e61eaaccfa9dfa50bb77d19f0380e6{\nbackground-color:#0c8a7b;\nborder-color:#0c8a7b;\ncolor:#ffffff;\n-webkit-transition:all 0.4s ease-in-out;\n-moz-transition:all 0.4s ease-in-out;\n-ms-transition:all 0.4s ease-in-out;\n-o-transition:all 0.4s ease-in-out;\ntransition:all 0.4s ease-in-out;\n}\n<\/style>\n<a href='#kontakt'  class='avia-button av-izrqrm-56e61eaaccfa9dfa50bb77d19f0380e6 avia-icon_select-no avia-size-x-large avia-position-left'  ><span class='avia_iconbox_title' >Request now<\/span><\/a><\/div><\/p><\/div><div class='flex_column av-7xn6jm-3f4716b52d8ea4d93a18cc1d8e1a1992 av_one_full  avia-builder-el-10  el_after_av_one_half  el_before_av_one_full  first flex_column_div column-top-margin'     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-67vo8y-61c5ff24a6ae6675f56efe41459e654e\">\n#top .hr.hr-invisible.av-67vo8y-61c5ff24a6ae6675f56efe41459e654e{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-67vo8y-61c5ff24a6ae6675f56efe41459e654e hr-invisible  avia-builder-el-11  el_before_hhac_cta_bar  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<div class=\"hhac-cta-bar\">\n\t<div class=\"hhac-cta-bar__heading\">\n\t\tWe will gladly <span class=\"md-block\">advise you<\/span>\t<\/div>\n\t<div class=\"hhac-cta-bar__email\">\n\t\t<div class=\"hhac-cta-bar__label\">Email<\/div>\n\t\t<a href=\"mailto:hhac@hhac.de\" class=\"hhac-cta-bar__link\">hhac@hhac.de<\/a>\n\t<\/div>\n\t<div class=\"hhac-cta-bar__phone\">\n\t\t<div class=\"hhac-cta-bar__label\">Phone<\/div>\n\t\t<a href=\"tel:+497249913020\" class=\"hhac-cta-bar__link\">+49 7249 91302-0<\/a>\n\t<\/div>\n\t<div class=\"hhac-cta-bar__action\">\n\t\t<a href=\"https:\/\/hhac.de\/en\/contact\/\" class=\"hhac-cta-bar__button\">Contact<\/a>\n\t<\/div>\n<\/div>\n<br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-34eonm-11819551e0414f654c60398c4759a1fd\">\n#top .hr.hr-invisible.av-34eonm-11819551e0414f654c60398c4759a1fd{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-34eonm-11819551e0414f654c60398c4759a1fd hr-invisible  avia-builder-el-13  el_after_hhac_cta_bar  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-44t4ky-2f563cfdf6e1cafb5517d15f6049040f\">\n.flex_column.av-44t4ky-2f563cfdf6e1cafb5517d15f6049040f{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-44t4ky-2f563cfdf6e1cafb5517d15f6049040f av_one_full  avia-builder-el-14  el_after_av_one_full  el_before_av_hr  first flex_column_div av-zero-column-padding column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-386sci-62052b95a7aef4082b32c7abc23beaba\">\n.avia-image-container.av-386sci-62052b95a7aef4082b32c7abc23beaba img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-386sci-62052b95a7aef4082b32c7abc23beaba .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-386sci-62052b95a7aef4082b32c7abc23beaba av-styling- avia-align-center  avia-builder-el-15  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" class='wp-image-3051 avia-img-lazy-loading-not-3051 avia_image ' src=\"https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-hhac-labor-dr-heusler.jpg\" alt='' title=''  height=\"779\" width=\"2000\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-hhac-labor-dr-heusler.jpg 2000w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-hhac-labor-dr-heusler-300x117.jpg 300w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-hhac-labor-dr-heusler-1030x401.jpg 1030w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-hhac-labor-dr-heusler-768x299.jpg 768w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-hhac-labor-dr-heusler-1536x598.jpg 1536w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-hhac-labor-dr-heusler-1500x584.jpg 1500w, https:\/\/hhac.de\/wp-content\/uploads\/2023\/01\/leistungen-stabilitaetspruefung-hhac-labor-dr-heusler-705x275.jpg 705w\" sizes=\"(max-width: 2000px) 100vw, 2000px\" \/><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-dxfj1e-593509f4e86639517d7f97841bb6cdd3\">\n#top .hr.hr-invisible.av-dxfj1e-593509f4e86639517d7f97841bb6cdd3{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-dxfj1e-593509f4e86639517d7f97841bb6cdd3 hr-invisible  avia-builder-el-16  el_after_av_one_full  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-opkfqa-2f3b151ad066c833c2dba9c3935fa426\">\n#top .av_textblock_section.av-opkfqa-2f3b151ad066c833c2dba9c3935fa426 .avia_textblock{\ncolor:#b8b9bb;\n}\n<\/style>\n<section  class='av_textblock_section av-opkfqa-2f3b151ad066c833c2dba9c3935fa426'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><h3>THE PROCESS<\/h3>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lr9pdu-2b5a701c9bb028dbd2be813ebfaca26c\">\n#top .hr.hr-invisible.av-lr9pdu-2b5a701c9bb028dbd2be813ebfaca26c{\nmargin-top:-50px;\nheight:1px;\n}\n<\/style>\n<div  class='hr av-lr9pdu-2b5a701c9bb028dbd2be813ebfaca26c hr-invisible  avia-builder-el-18  el_after_av_textblock  el_before_av_heading '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lbxh2wan-0af4c54bb88c871d42ed0f05e0f6efa5\">\n#top .av-special-heading.av-lbxh2wan-0af4c54bb88c871d42ed0f05e0f6efa5{\npadding-bottom:30px;\nfont-size:50px;\n}\nbody .av-special-heading.av-lbxh2wan-0af4c54bb88c871d42ed0f05e0f6efa5 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lbxh2wan-0af4c54bb88c871d42ed0f05e0f6efa5 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lbxh2wan-0af4c54bb88c871d42ed0f05e0f6efa5 .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-lbxh2wan-0af4c54bb88c871d42ed0f05e0f6efa5 .av-special-heading-tag{\nfont-size:30px;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-lbxh2wan-0af4c54bb88c871d42ed0f05e0f6efa5 .av-special-heading-tag{\nfont-size:30px;\n}\n}\n<\/style>\n<div  class='av-special-heading av-lbxh2wan-0af4c54bb88c871d42ed0f05e0f6efa5 av-special-heading-h2 blockquote modern-quote  avia-builder-el-19  el_after_av_hr  el_before_av_one_half  av-inherit-size'><h2 class='av-special-heading-tag'  itemprop=\"headline\"  >Every order starts <\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-axskky-f95c69c022975230cf3bc533f920a536\">\n.flex_column.av-axskky-f95c69c022975230cf3bc533f920a536{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-axskky-f95c69c022975230cf3bc533f920a536 av_one_half  avia-builder-el-20  el_after_av_heading  el_before_av_one_half  first flex_column_div av-zero-column-padding '     ><section  class='av_textblock_section av-lbxh8q4x-e1a3e9e2d199bf467e3a67a8067451da'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>with the <strong>determination of the required test samples<\/strong> and the <strong>creation of test plans<\/strong>. We then accompany you through the <strong>entire development and market phase<\/strong> (product life cycle). Regulatory stability tests, such as exploratory or confirmatory studies, are conducted under ICH conditions.<\/p>\n<p>To verify the shelf life of all products on the market, we conduct <strong>on-going studies<\/strong>. Test samples are stored in <strong>qualified climate facilities equipped with alarm systems<\/strong>, where the required climate conditions are consistently controlled and recorded.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ei4rqq-f8630a2dec0257c0a29952b0c49a7943\">\n.flex_column.av-ei4rqq-f8630a2dec0257c0a29952b0c49a7943{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-ei4rqq-f8630a2dec0257c0a29952b0c49a7943 av_one_half  avia-builder-el-22  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding '     ><section  class='av_textblock_section av-lbxhfkrk-2321bf35020a5e188c0ae3f1686486b1'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Photostability tests and stress tests under defined climatic conditions and exposure are also possible in our laboratory.<\/p>\n<p>On request, we will also undertake the <strong>development and validation of specific methods<\/strong> for you. And of course you will find all relevant work steps &#8211; GMP-compliant &#8211; in our documentation!<\/p>\n<\/div><\/section><\/div><\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id='after_section_1'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-3788'><div class='entry-content-wrapper clearfix'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ms8rfdw0-808d9bd8e07d66f66101f1eafb4c9cad\">\n#top .av-special-heading.av-ms8rfdw0-808d9bd8e07d66f66101f1eafb4c9cad{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-ms8rfdw0-808d9bd8e07d66f66101f1eafb4c9cad .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-ms8rfdw0-808d9bd8e07d66f66101f1eafb4c9cad .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-ms8rfdw0-808d9bd8e07d66f66101f1eafb4c9cad av-special-heading-h3 blockquote modern-quote  avia-builder-el-24  el_after_av_section  el_before_av_textblock  avia-builder-el-first '><h3 class='av-special-heading-tag'  itemprop=\"headline\"  >What Is a Stability Study?<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<section  class='av_textblock_section av-ms8rh1tk-4438f9530f2d4e0cd708670cb6002cb6'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>A stability study evaluates how the quality of a product changes over time under defined storage conditions. The following quality attributes are typically monitored:<\/p>\n<div>\n<ul>\n<li>Assay (active ingredient content)<\/li>\n<li>Purity<\/li>\n<li>Degradation products<\/li>\n<li>Dissolution<\/li>\n<li>Water content<\/li>\n<li>Physical parameters<\/li>\n<li>Microbiological parameters<\/li>\n<li>Packaging integrity<\/li>\n<\/ul>\n<p>The objective is to provide scientific evidence of shelf life and to establish appropriate storage conditions. Stability data form an essential basis for regulatory submissions, variation procedures, and ongoing post-marketing surveillance.<\/p>\n<\/div>\n<\/div><\/section>\n<div  class='hr av-av_hr-91d7ccd583a503147498e120fee2ff9b hr-default  avia-builder-el-26  el_after_av_textblock  el_before_av_heading '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ms8rhm6w-1144676b3d9c720c3b7ec51a99a19f72\">\n#top .av-special-heading.av-ms8rhm6w-1144676b3d9c720c3b7ec51a99a19f72{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-ms8rhm6w-1144676b3d9c720c3b7ec51a99a19f72 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-ms8rhm6w-1144676b3d9c720c3b7ec51a99a19f72 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-ms8rhm6w-1144676b3d9c720c3b7ec51a99a19f72 av-special-heading-h3 blockquote modern-quote  avia-builder-el-27  el_after_av_hr  el_before_av_textblock '><h3 class='av-special-heading-tag'  itemprop=\"headline\"  >Our Stability Testing Services<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ms8rkkg7-8871fb7cc470456f2d1e8456144ed980\">\n#top .av_textblock_section.av-ms8rkkg7-8871fb7cc470456f2d1e8456144ed980 .avia_textblock{\n-webkit-column-count:2;\n-moz-column-count:2;\ncolumn-count:2;\n}\n<\/style>\n<section  class='av_textblock_section av-ms8rkkg7-8871fb7cc470456f2d1e8456144ed980'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_multi_colums'  itemprop=\"text\" ><p>HHAC offers a complete range of services related to stability studies from a single source.<\/p>\n<div>\n<h4>Regulatory Stability Studies According to ICH<\/h4>\n<ul>\n<li>Long-term studies<\/li>\n<li>Intermediate studies<\/li>\n<li>Accelerated studies<\/li>\n<li>Confirmatory studies<\/li>\n<li>Exploratory studies<\/li>\n<\/ul>\n<p>All studies are conducted in accordance with relevant ICH requirements and under controlled climatic conditions.<\/p>\n<p>Testing of light-sensitive active ingredients and products in accordance with ICH Q1B.<\/p>\n<h4>In-Use Stability Studies<\/h4>\n<p>Assessment of product stability after opening or reconstitution.<\/p>\n<h4>Transportation and Temperature-Cycling Studies<\/h4>\n<p>Simulation of transport and storage conditions to evaluate their potential impact on product quality.<\/p>\n<h4>Stress Testing<\/h4>\n<p>Investigation of degradation behavior under defined stress conditions such as temperature, humidity, or light exposure.<\/p>\n<h4>Ongoing Stability Programs<\/h4>\n<p>Periodic monitoring of marketed products to confirm their approved shelf life.<\/p>\n<\/div>\n<\/div><\/section>\n<div  class='hr av-av_hr-91d7ccd583a503147498e120fee2ff9b hr-default  avia-builder-el-29  el_after_av_textblock  el_before_av_heading '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ms8rlhwe-9a5d556e9c63efc11af59e58a3001829\">\n#top .av-special-heading.av-ms8rlhwe-9a5d556e9c63efc11af59e58a3001829{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-ms8rlhwe-9a5d556e9c63efc11af59e58a3001829 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-ms8rlhwe-9a5d556e9c63efc11af59e58a3001829 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-ms8rlhwe-9a5d556e9c63efc11af59e58a3001829 av-special-heading-h3 blockquote modern-quote  avia-builder-el-30  el_after_av_hr  el_before_av_textblock '><h3 class='av-special-heading-tag'  itemprop=\"headline\"  >From Study Design to Final Report<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<section  class='av_textblock_section av-ms8rmzfl-0729fba39a7fa5c6f26f8d6e677eedcc'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Our services include:<\/p>\n<div>\n<ul>\n<li>Determination of sample amounts<\/li>\n<li>Preparation of study protocols<\/li>\n<li>Definition of storage conditions<\/li>\n<li>GMP-compliant storage<\/li>\n<li>Timely retrieval of samples<\/li>\n<li>Analytical testing<\/li>\n<li>Trend analysis<\/li>\n<li>Final reporting and documentation<\/li>\n<\/ul>\n<p>Upon request, we also develop and validate product-specific analytical methods or transfer existing methods as part of a structured method transfer program.<\/p>\n<\/div>\n<\/div><\/section>\n<div  class='hr av-av_hr-91d7ccd583a503147498e120fee2ff9b hr-default  avia-builder-el-32  el_after_av_textblock  el_before_av_heading '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ms8rne45-63a70ac42f6b0a3d06f76e15a8e788a9\">\n#top .av-special-heading.av-ms8rne45-63a70ac42f6b0a3d06f76e15a8e788a9{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-ms8rne45-63a70ac42f6b0a3d06f76e15a8e788a9 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-ms8rne45-63a70ac42f6b0a3d06f76e15a8e788a9 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-ms8rne45-63a70ac42f6b0a3d06f76e15a8e788a9 av-special-heading-h3 blockquote modern-quote  avia-builder-el-33  el_after_av_hr  el_before_av_textblock '><h3 class='av-special-heading-tag'  itemprop=\"headline\"  >Why HHAC?<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<section  class='av_textblock_section av-ms8rp4kq-c6b1950c5af9a2e0b5db541516c91872'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h4><span style=\"font-size: 20px; font-weight: 600;\">More Than 30 Years of Experience in Pharmaceutical Analytics<\/span><\/h4>\n<div>\n<p>Since 1992, HHAC has supported pharmaceutical companies with analytical challenges, method development, and stability testing. The laboratory has experience with more than 400 active pharmaceutical ingredients and excipients across a wide variety of dosage forms.<\/p>\n<h4>Your Benefits<\/h4>\n<ul>\n<li>GMP-compliant execution<\/li>\n<li>Storage and analytical testing from a single source<\/li>\n<li>Dedicated contacts and project support<\/li>\n<li>Assistance with study protocols and sample planning<\/li>\n<li>Flexible project management<\/li>\n<li>Experience with pharmaceuticals, medical devices, and cosmetics<\/li>\n<li>Extensive expertise in regulatory requirements<\/li>\n<\/ul>\n<\/div>\n<\/div><\/section>\n<div  class='hr av-av_hr-91d7ccd583a503147498e120fee2ff9b hr-default  avia-builder-el-35  el_after_av_textblock  el_before_av_heading '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ms8t2s5n-14430a094f18163dcf70f0b4cfb4c4d5\">\n#top .av-special-heading.av-ms8t2s5n-14430a094f18163dcf70f0b4cfb4c4d5{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-ms8t2s5n-14430a094f18163dcf70f0b4cfb4c4d5 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-ms8t2s5n-14430a094f18163dcf70f0b4cfb4c4d5 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-ms8t2s5n-14430a094f18163dcf70f0b4cfb4c4d5 av-special-heading-h3 blockquote modern-quote  avia-builder-el-36  el_after_av_hr  el_before_av_toggle_container '><h3 class='av-special-heading-tag'  itemprop=\"headline\"  >FAQs<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<div  class='togglecontainer av-ms8rx4c0-5add7a9778f67f2b7d0513291e7b0aa8  avia-builder-el-37  el_after_av_heading  avia-builder-el-last  toggle_close_all' >\n<section class='av_toggle_section av-ms8rscci-7f0a28340d552f7f799d67a16acd024e'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p data-fake-id='#toggle-id-1' class='toggler   '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-1'>How long does a stability study take?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-1' class='toggle_wrap  '  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The duration depends on the study objective. Accelerated studies can often be completed within a few months, whereas long-term studies typically run for 12, 24, or 36 months.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-ms8rsyya-186befb6b4e6227d576c58d1a67650c2'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p data-fake-id='#toggle-id-2' class='toggler   '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-2'>Which ICH guidelines are relevant for stability testing?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-2' class='toggle_wrap  '  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>For pharmaceuticals, the ICH Q1 series is particularly relevant. These guidelines include requirements for long-term, intermediate, and accelerated stability studies, as well as photostability testing.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-ms8rth41-a38bb6777ad03a871b123d68a4af0b01'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p data-fake-id='#toggle-id-3' class='toggler   '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-3'>Which products can be evaluated in stability studies?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-3' class='toggle_wrap  '  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>We conduct stability testing for active pharmaceutical ingredients, finished pharmaceutical products, medical devices, cosmetics, and other regulated products.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-ms8ru6np-23235d22a65cce5f07daf118dae6c8bc'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p data-fake-id='#toggle-id-4' class='toggler   '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-4'>Which storage conditions are available for stability studies?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-4' class='toggle_wrap  '  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>Standard controlled conditions include:<\/p>\n<div>\n<ul>\n<li>25\u00b0C \/ 60% RH<\/li>\n<li>30\u00b0C \/ 65% RH<\/li>\n<li>30\u00b0C \/ 75% RH<\/li>\n<li>40\u00b0C \/ 75% RH<\/li>\n<li>5\u00b0C<\/li>\n<li>-20\u00b0C<\/li>\n<\/ul>\n<p>Additional storage conditions are available upon request.<\/p>\n<\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-ms8ruygq-deb45de20d3d195a0c6ae5e3f9bbe6ea'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p data-fake-id='#toggle-id-5' class='toggler   '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-5'>What is the difference between long-term and accelerated studies?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-5' class='toggle_wrap  '  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>Long-term studies simulate actual storage conditions over extended periods. Accelerated studies use elevated stress conditions to reveal potential product changes more rapidly.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-ms8rvoxp-6061e414884a96441daabd6330bdc68d'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p data-fake-id='#toggle-id-6' class='toggler   '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-6'>Can analytical methods for stability studies be newly developed or validated?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-6' class='toggle_wrap  '  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>Yes. HHAC supports clients with method development, validation, and optimization of analytical procedures for stability studies.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-ms8rw94z-ca4fabe84786b749e47ecdb2adf50f2c'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p data-fake-id='#toggle-id-7' class='toggler   '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-7'>What are ongoing stability studies?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-7' class='toggle_wrap  '  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>Ongoing stability studies provide continuous monitoring of marketed products and confirm the shelf life established during the regulatory approval process.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-ms8rx2um-a70f1c51771eee8a5f371b56e85c5833'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p data-fake-id='#toggle-id-8' class='toggler   '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-8'>Does HHAC support the planning of stability studies?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-8' class='toggle_wrap  '  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>Yes. We assist with determining sample amounts, preparing study protocols, and selecting appropriate storage and testing conditions.<\/p>\n<\/div><\/div><\/div><\/section>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":13,"featured_media":0,"parent":3781,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-3788","page","type-page","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/hhac.de\/en\/wp-json\/wp\/v2\/pages\/3788","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hhac.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/hhac.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/hhac.de\/en\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/hhac.de\/en\/wp-json\/wp\/v2\/comments?post=3788"}],"version-history":[{"count":3,"href":"https:\/\/hhac.de\/en\/wp-json\/wp\/v2\/pages\/3788\/revisions"}],"predecessor-version":[{"id":5137,"href":"https:\/\/hhac.de\/en\/wp-json\/wp\/v2\/pages\/3788\/revisions\/5137"}],"up":[{"embeddable":true,"href":"https:\/\/hhac.de\/en\/wp-json\/wp\/v2\/pages\/3781"}],"wp:attachment":[{"href":"https:\/\/hhac.de\/en\/wp-json\/wp\/v2\/media?parent=3788"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}