{"id":52,"date":"2024-04-04T00:39:48","date_gmt":"2024-04-03T21:39:48","guid":{"rendered":"https:\/\/sisu.ut.ee\/lcms_method_validation\/8-stability\/"},"modified":"2024-05-08T14:02:24","modified_gmt":"2024-05-08T11:02:24","slug":"8-stability","status":"publish","type":"page","link":"https:\/\/sisu.ut.ee\/lcms_method_validation\/8-stability\/","title":{"rendered":"8. Stability"},"content":{"rendered":"<p>In this part of the course the issues related to the analyte\u2019s (insufficient) stability are introduced and explained. In addition,\u00a0different\u00a0approaches are proposed how to deal with unstable analytes. \u00a0<\/p>\n<h5 style=\"text-align: center;\"><div class=\"ratio ratio-16x9 mb-3\"><div class=\"video-placeholder-wrapper video-placeholder-wrapper--16x9\">\n\t\t\t    <div class=\"video-placeholder d-flex justify-content-center align-items-center\">\n\t\t\t        <div class=\"overlay text-white p-2 w-100 text-center d-block justify-content-center align-items-center\">\n\t\t\t            <div>To view third-party content, please accept cookies.<\/div>\n\t\t\t            <button class=\"btn btn-secondary btn-sm mt-1 consent-change\">Change consent<\/button>\n\t\t\t        <\/div>\n\t\t\t    <\/div>\n\t\t\t<\/div>\n<\/div><\/h5>\n<h5 style=\"text-align: center;\">Stability introduction<\/h5>\n<h5 style=\"text-align: center;\"><a style=\"text-align: center; font-family: inherit; font-weight: 600;\" href=\"http:\/\/www.uttv.ee\/naita?id=23632\" target=\"_blank\" rel=\"noopener\">http:\/\/www.uttv.ee\/naita?id=23632<\/a><\/h5>\n<h5 style=\"text-align: center;\"><a style=\"font-family: roboto, arial, sans-serif; font-weight: 600;\" href=\"https:\/\/www.youtube.com\/watch?v=1XaPGinpkfQ&amp;feature=youtu.be\" target=\"_blank\" rel=\"noopener\">https:\/\/www.youtube.com\/watch?v=1XaPGinpkfQ&amp;feature=youtu.be<\/a><\/h5>\n<p>Analyte stability is universally not\u00a0included in the validation guidelines as a validation parameter\u00a0(it is included only in SANTE\/SANCO, EU regulation 2021\/808, EMA, FDA and AOAC). The reason for this is that if the analyte is unstable, its decomposition influences the trueness\u00a0and precision\u00a0of the procedure and is, thus, accounted for by these two parameters.\u00a0However, stability is a very important parameter in bioanalytics and this importance justifies considering\u00a0it as a separate performance parameter. In bioanalytics the instability of an analyte is rather a rule, not an exception. Therefore, it is necessary to find out whether the analyte\u00a0is unstable, how unstable it is, could we change the\u00a0conditions in our method to improve\u00a0analytes\u2019\u00a0stability and, finally, how can we still get acceptable results if an\u00a0analyte is unstable.<\/p>\n<p>Analyte stability must be ensured during the\u00a0<strong>sample collection, processing, storage, handling, extraction and duration of the analysis <\/strong>in order\u00a0to generate reliable (bio)analytical data. Therefore, the stability tests can be among the most time-consuming tests in the validation procedure.<\/p>\n<p>Stability is the lowering of the\u00a0analyte content in the sample over period of time.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-427\" style=\"margin-right: auto; margin-left: auto;\" title=\"image001.png\" src=\"https:\/\/sisu.ut.ee\/wp-content\/uploads\/sites\/130\/image001-9.png\" alt=\"image001.png\" width=\"440\" height=\"250\" srcset=\"https:\/\/sisu.ut.ee\/wp-content\/uploads\/sites\/130\/image001-9.png 581w, https:\/\/sisu.ut.ee\/wp-content\/uploads\/sites\/130\/image001-9-300x170.png 300w\" sizes=\"auto, (max-width: 440px) 100vw, 440px\"><\/p>\n<div>\n<div>\n<h4 style=\"text-align: center;\"><strong>Figure 1.\u00a0 <\/strong>Analyte stability over the period of time.<\/h4>\n<\/div>\n<\/div>\n<p>If an\u00a0analyte is stable, then the concentration remains the same in time e. g. 100%. If an analyte degrades with time, then its concentration is decreased and also the stability is lower than 100%.<\/p>\n<p>Decomposition usually leads to a decrease in analyte content. However, in the case of analysis of decomposition products, degradation can lead to an increase in the analyte content.<\/p>\n<p>If an\u00a0analyte is unstable, its decomposition influences the trueness and precision (since both systematic and random effects are usually involved) of the procedure and is, thus, indirectly\u00a0accounted for by these two parameters. It is nevertheless useful to handle analyte stability separately from trueness and precision.<\/p>\n<p>The rate of decomposition can be strongly dependent on the minor experimental details (type of matrix, access of oxygen, temperature, light etc.).<\/p>\n<p>Furthermore, besides the analyte in the samples, analyte in the standards can also decompose. If both occur at the same rate, the\u00a0decomposition only affects precision. If not, then both trueness and precision are affected. In addition, the EMA guide [ref 7] stresses that analyte stability cannot be proven by literature data, further outlining the importance of analyte stability testing.\u00a0<\/p>\n<div>\n<div>\n<div id=\"_com_1\" class=\"msocomtxt\"><!-- [if !supportAnnotations]--><\/div>\n<p><!--[endif]--><\/p>\n<\/div>\n<\/div>\n\n\n<div class=\"wp-block-group attached-files-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-d43dba8b-8f96-43c1-b3b2-90ba633bd5aa\" href=\"https:\/\/sisu.ut.ee\/wp-content\/uploads\/sites\/130\/8_stability_introduction.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">8_stability_introduction.pdf<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In this part of the course the issues related to the analyte\u2019s (insufficient) stability are introduced and explained. In addition,\u00a0different\u00a0approaches are proposed how to deal with unstable analytes. \u00a0 To view third-party content, please accept cookies. Change consent Stability introduction &#8230;<\/p>\n","protected":false},"author":60,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-52","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/pages\/52","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/users\/60"}],"replies":[{"embeddable":true,"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/comments?post=52"}],"version-history":[{"count":4,"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/pages\/52\/revisions"}],"predecessor-version":[{"id":1288,"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/pages\/52\/revisions\/1288"}],"wp:attachment":[{"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/media?parent=52"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}