{"id":4090,"date":"2024-10-25T13:28:15","date_gmt":"2024-10-25T09:58:15","guid":{"rendered":"https:\/\/shimisanj.com\/validation-of-analysis-methods\/"},"modified":"2025-08-22T19:19:46","modified_gmt":"2025-08-22T15:49:46","slug":"validation-of-analysis-methods","status":"publish","type":"post","link":"https:\/\/shimisanj.com\/en\/validation-of-analysis-methods\/","title":{"rendered":"Validation of analysis methods"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4090\" class=\"elementor elementor-4090\" data-elementor-settings=\"{&quot;element_pack_global_tooltip_width&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_width_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_width_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_padding&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_padding_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_padding_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true}}\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f8142b3 e-flex e-con-boxed e-con e-parent\" data-id=\"f8142b3\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4b5e65e bdt-backdrop-filter-yes elementor-widget elementor-widget-heading\" data-id=\"4b5e65e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h2 class=\"elementor-heading-title elementor-size-default\">Validation of analysis methods<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-20d920e e-flex e-con-boxed e-con e-parent\" data-id=\"20d920e\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d7511ce elementor-widget elementor-widget-heading\" data-id=\"d7511ce\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Validation of analysis methods includes:<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-97d0cff e-flex e-con-boxed e-con e-parent\" data-id=\"97d0cff\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c12d2e elementor-widget elementor-widget-text-editor\" data-id=\"2c12d2e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<h2 lang=\"en\"><strong>Analytical Method Development and Validation<\/strong><\/h2><p lang=\"en\">Validation of measurement methods used in the pharmaceutical industry is a regulatory requirement of pharmaceutical pharmacopoeias and drug authorities. Method validation demonstrates that the generated measurement data are <strong>accurate<\/strong>, <strong>reliable<\/strong>, <strong>reproducible<\/strong>, and suitable for the intended application.<\/p><p lang=\"en\">The requirements for validation of pharmaceutical analytical methods are described in the <strong>USP &lt;1225&gt;<\/strong> and <strong>ICH Q2 (R1)<\/strong> guidelines.<\/p><p lang=\"en\">At Arman Shimi Sanj, upon client request, we first carry out <strong>analytical method development<\/strong>, followed by method validation in accordance with pharmaceutical pharmacopoeias, <strong>ICH Q2 (R1)<\/strong> guidance, the client\u2019s own specific protocol, and\/or the company\u2019s internal protocol.<\/p><p lang=\"en\">Key <strong>performance characteristics<\/strong> evaluated during method validation include:<\/p><ul lang=\"en\"><li><strong>Accuracy<\/strong><\/li><li><strong>Repeatability<\/strong><\/li><li><strong>Reproducibility<\/strong><\/li><li><strong>Linearity and Linear Range<\/strong><\/li><li><strong>Limit of Detection (LOD)<\/strong> and <strong>Limit of Quantification (LOQ)<\/strong><\/li><li><strong>Method Robustness<\/strong><\/li><\/ul><p lang=\"en\">Additional specific characteristics can also be evaluated upon request.<\/p><p lang=\"en\">The final report provided by our company clearly describes the obtained results, the test method, the protocol used, the instruments and chemical reagents applied, as well as all statistical calculations performed. All chromatograms, spectra, and other instrumental reports are attached to the final documentation.<\/p><p lang=\"en\">We take pride in having provided <strong>high\u2011quality, accurate, and timely<\/strong> services tailored to the needs of numerous pharmaceutical companies across the country. This is just one of the many specialized pharmaceutical services we can offer our clients.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Validation of analysis methods Validation of analysis methods includes: Analytical Method Development and Validation Validation of measurement methods used in the pharmaceutical industry is a regulatory requirement of pharmaceutical pharmacopoeias and drug authorities. Method validation demonstrates that the generated measurement data are accurate, reliable, reproducible, and suitable for the intended application. The requirements for validation [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[130],"tags":[],"class_list":["post-4090","post","type-post","status-publish","format-standard","hentry","category-130"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.1 (Yoast SEO v25.2) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Validation of analysis methods - \u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/shimisanj.com\/\u0645\u0639\u062a\u0628\u0631-\u0633\u0627\u0632\u06cc-\u0631\u0648\u0634-\u0647\u0627\u06cc-\u0622\u0646\u0627\u0644\u06cc\u0632\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Validation of analysis methods\" \/>\n<meta property=\"og:description\" content=\"Validation of analysis methods Validation of analysis methods includes: Analytical Method Development and Validation Validation of measurement methods used in the pharmaceutical industry is a regulatory requirement of pharmaceutical pharmacopoeias and drug authorities. 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