{"id":1032,"date":"2023-09-25T10:38:36","date_gmt":"2023-09-25T09:38:36","guid":{"rendered":"https:\/\/www.consultlhasa.com\/?page_id=1032"},"modified":"2024-03-06T15:33:35","modified_gmt":"2024-03-06T15:33:35","slug":"potentially-mutagenic-impurities","status":"publish","type":"page","link":"https:\/\/www.consultlhasa.com\/es\/our-services\/potentially-mutagenic-impurities\/","title":{"rendered":"Impurezas potencialmente mutag\u00e9nicas"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1032\" class=\"elementor elementor-1032\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-263d6bb elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"263d6bb\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[],&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-45b9119\" data-id=\"45b9119\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-b0610fa elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b0610fa\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-3e42139\" data-id=\"3e42139\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-662321d\" data-id=\"662321d\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7f0dac4 elementor-widget elementor-widget-heading\" data-id=\"7f0dac4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Potentially mutagenic impurities<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f2b4b9d elementor-widget elementor-widget-heading\" data-id=\"f2b4b9d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Supporting your computational assessment and control of potentially mutagenic impurities (PMIs)<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-e1cc50d\" data-id=\"e1cc50d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-908af30 elementor-widget elementor-widget-spacer\" data-id=\"908af30\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7b3030 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"f7b3030\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.consultlhasa.com\/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\">Get in touch<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0eff82d elementor-widget elementor-widget-spacer\" data-id=\"0eff82d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8bf8cae elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"8bf8cae\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" d=\"m55.51,63.64L103.25,7.25c2.42-2.86.39-7.25-3.36-7.25H4.41C.66,0-1.37,4.39,1.05,7.25l47.74,56.39c1.76,2.08,4.96,2.08,6.72,0Z\"><\/path><\/g><\/svg><\/div>\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>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-de62296 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"de62296\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-aeddcf2\" data-id=\"aeddcf2\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dcde475 elementor-widget elementor-widget-heading\" data-id=\"dcde475\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Assessment and control of PMIs<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3a53ca9 elementor-widget elementor-widget-text-editor\" data-id=\"3a53ca9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Once a potentially mutagenic impurity (PMI) is identified, in cases when there is no experimental data to support a risk assessment, <em>in silico<\/em> methodologies can be used to assess the mutagenic potential of impurities under ICH M7.<\/p><p>In line with this guideline, impurities can be classified using <em>in silico<\/em> tools alongside expert review instead of <em>in vitro<\/em> and <em>in vivo<\/em> testing, resulting in a more ethical &#8211; through the reduction of animal testing &#8211; and cost-effective approach.<\/p><p>Depending on the resulting impurity classification, a control strategy must be defined \u2013 considering impurity characteristics and the API process \u2013 to limit potential carcinogenic risk and result in chemical safety.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-5250c56\" data-id=\"5250c56\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1227ada elementor-widget elementor-widget-global elementor-global-2396 elementor-widget-html\" data-id=\"1227ada\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<script src=\"https:\/\/js-eu1.hsforms.net\/forms\/embed\/147317948.js\" defer><\/script>\r\n<div class=\"hs-form-frame\" data-region=\"eu1\" data-form-id=\"a022f0e3-73a1-4ed3-819c-cd65e35d0045\" data-portal-id=\"147317948\"><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5344968 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5344968\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ef51f5f\" data-id=\"ef51f5f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ac05fc2 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"ac05fc2\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" d=\"m55.51,63.64L103.25,7.25c2.42-2.86.39-7.25-3.36-7.25H4.41C.66,0-1.37,4.39,1.05,7.25l47.74,56.39c1.76,2.08,4.96,2.08,6.72,0Z\"><\/path><\/g><\/svg><\/div>\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>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4fe423f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4fe423f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-8b4eebb\" data-id=\"8b4eebb\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-79b1df7 elementor-widget elementor-widget-spacer\" data-id=\"79b1df7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-ac4beeb\" data-id=\"ac4beeb\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b2d234c elementor-widget elementor-widget-heading\" data-id=\"b2d234c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why choose Consult Lhasa?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d1629b9 elementor-widget elementor-widget-text-editor\" data-id=\"d1629b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Consult Lhasa offer expert risk assessments for potentially mutagenic impurities (PMIs), grounded in the trusted and recognised science of Lhasa Limited. With over 40 years of collaboration with industry and regulatory authorities, Lhasa Limited has been at the forefront of PMI <em>in silico<\/em> assessment science. This has led to clear alignment with the global impurity guideline, ICH M7.<\/p><p>For assistance with computational assessment and control of your PMIs, <a href=\"https:\/\/www.consultlhasa.com\/contact-us\"><strong>Consult Lhasa<\/strong><\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-0706e69 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0706e69\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3d0fe54\" data-id=\"3d0fe54\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8173837 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"8173837\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" d=\"m55.51,63.64L103.25,7.25c2.42-2.86.39-7.25-3.36-7.25H4.41C.66,0-1.37,4.39,1.05,7.25l47.74,56.39c1.76,2.08,4.96,2.08,6.72,0Z\"><\/path><\/g><\/svg><\/div>\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>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e5e2a8d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e5e2a8d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b736eab\" data-id=\"b736eab\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dffce71 elementor-widget elementor-widget-heading\" data-id=\"dffce71\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How can our experts help you to assess\n<br>potentially mutagenic impurities?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba1773a elementor-widget elementor-widget-jet-accordion\" data-id=\"ba1773a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"jet-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"jet-accordion\" data-settings=\"{&quot;collapsible&quot;:false,&quot;ajaxTemplate&quot;:false,&quot;switchScrolling&quot;:false,&quot;switchScrollingTablet&quot;:false,&quot;switchScrollingMobile&quot;:false,&quot;switchScrollingOffset&quot;:{&quot;size&quot;:0,&quot;unit&quot;:&quot;px&quot;},&quot;switchScrollingOffsetTablet&quot;:{&quot;size&quot;:0,&quot;unit&quot;:&quot;px&quot;},&quot;switchScrollingOffsetMobile&quot;:{&quot;size&quot;:0,&quot;unit&quot;:&quot;px&quot;},&quot;switchScrollingDelay&quot;:500,&quot;switchScrollingDelayTablet&quot;:500,&quot;switchScrollingDelayMobile&quot;:500}\">\n\t\t\t<div class=\"jet-accordion__inner\">\n\t\t\t\t<div class=\" jet-accordion__item jet-toggle jet-toggle-move-up-effect \">\n\t\t\t\t\t\t\t<div id=\"jet-toggle-control-1951\" class=\"jet-toggle__control elementor-menu-anchor\" data-toggle=\"1\" role=\"button\" tabindex=\"0\" aria-controls=\"jet-toggle-content-1951\" aria-expanded=\"false\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__label-icon jet-toggle-icon-position-right\"><span class=\"jet-toggle__icon icon-normal jet-tabs-icon\"><i class=\"fas fa-caret-down\"><\/i><\/span><span class=\"jet-toggle__icon icon-active jet-tabs-icon\"><i class=\"fas fa-caret-up\"><\/i><\/span><\/div><div class=\"jet-toggle__label-text\">Classification of potentially mutagenic impurities (PMIs)<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div id=\"jet-toggle-content-1951\" class=\"jet-toggle__content\" data-toggle=\"1\" role=\"region\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__content-inner\"><hr \/><p><strong><br \/>Are you looking for support in classifying the PMIs of your active ingredient, in accordance with ICH M7?<br \/><\/strong>A computational toxicology assessment under ICH M7 is conducted using two (Q)SAR methodologies, which collectively predict the result of a bacterial mutagenicity test. In line with the ICH M7 guideline, we offer a complete toxicological assessment of your PMIs, in relation to your active pharmaceutical ingredient (API). This is achieved using Lhasa Limited (Q)SAR tools &#8211; expert rule-based system, Derek Nexus and statistical system, Sarah Nexus &#8211; which are aligned with OECD principles. After applying Consult Lhasa expert review &#8211; a critical aspect of an ICH M7 submission &#8211; we will provide you with an ICH M7 classification for each of your impurities.<\/p><p><strong><br \/>Do you know how to define the acceptable limits for your PMIs?<br \/><\/strong>The approach for calculating an acceptable limit varies based on the ICH M7 classification assigned to each impurity. We can assist you in determining the acceptable limits for your impurities.<\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div><div class=\" jet-accordion__item jet-toggle jet-toggle-move-up-effect \">\n\t\t\t\t\t\t\t<div id=\"jet-toggle-control-1952\" class=\"jet-toggle__control elementor-menu-anchor\" data-toggle=\"2\" role=\"button\" tabindex=\"0\" aria-controls=\"jet-toggle-content-1952\" aria-expanded=\"false\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__label-icon jet-toggle-icon-position-right\"><span class=\"jet-toggle__icon icon-normal jet-tabs-icon\"><i class=\"fas fa-caret-down\"><\/i><\/span><span class=\"jet-toggle__icon icon-active jet-tabs-icon\"><i class=\"fas fa-caret-up\"><\/i><\/span><\/div><div class=\"jet-toggle__label-text\">Control strategy definition<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div id=\"jet-toggle-content-1952\" class=\"jet-toggle__content\" data-toggle=\"2\" role=\"region\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__content-inner\"><hr \/><p><strong><br \/>Do you need help selecting a control strategy for your impurities?<br \/><\/strong>A control strategy must be selected when an impurity is classified as class 1, 2, or 3 in accordance with ICH M7. The ICH M7 guideline offers four potential control strategies, which should be selected based on scientific reasoning. We can evaluate your impurity and process characteristics to propose an appropriate control strategy.<\/p><p><strong><br \/>Do you need support justifying your ICH M7 control Option 3 or 4?<br \/><\/strong>If control Option 3 or 4 under ICH M7 is an appropriate control strategy, a purge argument can form part, if not all, of the justification. We can provide a scientifically sound and consistent purge calculation using Mirabilis and the expert knowledge of Consult Lhasa to improve your regulatory submission.<\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-50c3a40 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"50c3a40\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-723c5a4\" data-id=\"723c5a4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-855e7f4 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"855e7f4\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" d=\"m55.51,63.64L103.25,7.25c2.42-2.86.39-7.25-3.36-7.25H4.41C.66,0-1.37,4.39,1.05,7.25l47.74,56.39c1.76,2.08,4.96,2.08,6.72,0Z\"><\/path><\/g><\/svg><\/div>\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>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-122d0d2 elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"122d0d2\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[],&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a9976f7\" data-id=\"a9976f7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8720a27 elementor-widget elementor-widget-heading\" data-id=\"8720a27\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">We provide regulatory support<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-06c8165 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"06c8165\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-narrow\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-f002d0e\" data-id=\"f002d0e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-4dc7357\" data-id=\"4dc7357\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-852d687 elementor-flip-box--effect-flip elementor-flip-box--direction-up elementor-widget elementor-widget-flip-box\" data-id=\"852d687\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"flip-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-flip-box\" tabindex=\"0\">\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__front\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__image\">\n\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"177\" height=\"177\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/08\/ich-m7.svg\" class=\"attachment-full size-full wp-image-675\" alt=\"\" \/>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\t\tDiscover more\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__back\">\n\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\tICH M7\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\tFor assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, to limit potential carcinogenic risk.\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-bf3b06f\" data-id=\"bf3b06f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6d8f0df elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6d8f0df\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c115510\" data-id=\"c115510\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8161fe5 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"8161fe5\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" d=\"m55.51,63.64L103.25,7.25c2.42-2.86.39-7.25-3.36-7.25H4.41C.66,0-1.37,4.39,1.05,7.25l47.74,56.39c1.76,2.08,4.96,2.08,6.72,0Z\"><\/path><\/g><\/svg><\/div>\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>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e4025e0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e4025e0\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f4e8c8e\" data-id=\"f4e8c8e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a52f741 elementor-arrows-position-inside elementor-widget elementor-widget-global elementor-global-2143 elementor-widget-loop-carousel\" data-id=\"a52f741\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;template_id&quot;:1885,&quot;slides_to_show&quot;:&quot;1&quot;,&quot;slides_to_show_tablet&quot;:&quot;1&quot;,&quot;slides_to_show_laptop&quot;:&quot;1&quot;,&quot;slides_to_show_tablet_extra&quot;:&quot;1&quot;,&quot;_skin&quot;:&quot;post&quot;,&quot;slides_to_show_mobile&quot;:&quot;1&quot;,&quot;slides_to_scroll&quot;:&quot;1&quot;,&quot;edit_handle_selector&quot;:&quot;.elementor-loop-container&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;autoplay_speed&quot;:5000,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;infinite&quot;:&quot;yes&quot;,&quot;speed&quot;:500,&quot;offset_sides&quot;:&quot;none&quot;,&quot;arrows&quot;:&quot;yes&quot;,&quot;image_spacing_custom&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;image_spacing_custom_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_tablet_extra&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"loop-carousel.post\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"swiper elementor-loop-container elementor-grid\" role=\"list\" dir=\"ltr\">\n\t\t\t\t<div class=\"swiper-wrapper\" aria-live=\"off\">\n\t\t<style id=\"loop-1885\">.elementor-1885 .elementor-element.elementor-element-7e552b6{margin-top:30px;margin-bottom:30px;}.elementor-bc-flex-widget .elementor-1885 .elementor-element.elementor-element-169dc22.elementor-column .elementor-widget-wrap{align-items:center;}.elementor-1885 .elementor-element.elementor-element-169dc22.elementor-column.elementor-element[data-element_type=\"column\"] > .elementor-widget-wrap.elementor-element-populated{align-content:center;align-items:center;}.elementor-1885 .elementor-element.elementor-element-169dc22 > .elementor-element-populated{margin:0px 0px 0px 20px;--e-column-margin-right:0px;--e-column-margin-left:20px;}.elementor-widget-theme-post-content{color:var( --e-global-color-text 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.elementor-element.elementor-element-22125ee.elementor-column.elementor-element[data-element_type=\"column\"] > .elementor-widget-wrap.elementor-element-populated{align-content:center;align-items:center;}.elementor-widget-image .widget-image-caption{color:var( --e-global-color-text );font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-weight:var( --e-global-typography-text-font-weight );}.elementor-1885 .elementor-element.elementor-element-f2a53c7 .elementor-wrapper{--video-aspect-ratio:1.77777;}@media(max-width:767px){.elementor-1885 .elementor-element.elementor-element-9839265{font-size:16px;}.elementor-1885 .elementor-element.elementor-element-2397f38 .elementor-heading-title{font-size:16px;}}<\/style>\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"1885\" class=\"elementor elementor-1885 swiper-slide e-loop-item e-loop-item-1884 post-1884 testimonial type-testimonial status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" role=\"group\" aria-roledescription=\"slide\" data-custom-edit-handle=\"1\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7e552b6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7e552b6\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-169dc22\" data-id=\"169dc22\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9839265 elementor-widget elementor-widget-theme-post-content\" data-id=\"9839265\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-content.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p>&#8220;Our experience with Consult Lhasa has been very positive, resulting in a final report that we are confident will meet the scope required by regulatory agencies. The Consult Lhasa team are knowledgeable about the regulatory needs of the region, particularly Brazil, and provide great support. Their consulting has been invaluable to our company, the technical, scientific and human exchange has been impeccable. We are very satisfied with the collaboration.&#8221;<\/p>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2397f38 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"2397f38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Adriana Tomalino, Head of Regulatory Affairs at Triquim<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-22125ee\" data-id=\"22125ee\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa07a5b elementor-widget elementor-widget-image\" data-id=\"aa07a5b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1080\" height=\"1080\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image.png\" class=\"attachment-full size-full wp-image-1833\" alt=\"Adriana Tomalino testimonial image\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image.png 1080w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image-1024x1024.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image-768x768.png 768w\" sizes=\"(max-width: 1080px) 100vw, 1080px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"1885\" class=\"elementor elementor-1885 swiper-slide e-loop-item e-loop-item-2763 post-2763 testimonial type-testimonial status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" role=\"group\" aria-roledescription=\"slide\" data-custom-edit-handle=\"1\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7e552b6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7e552b6\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-169dc22\" data-id=\"169dc22\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9839265 elementor-widget elementor-widget-theme-post-content\" data-id=\"9839265\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-content.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p>&#8220;We recently had the experience of collaborating with Consult Lhasa to address an EU regulatory deficiency on a potential degradation impurity of the drug substance. Consult Lhasa made an intriguing task look simple in the final report which was based on Zeneth, literature review and expert analysis. Their professionalism and commitment to excellence were truly commendable and their proactive approach made the entire process seamless and ensured that we met the stringent regulatory timelines. Their core scientific knowledge, hands-on experience with the pharmaceutical industry and caliber of their work make them a standout choice. It is evident that they take great pride in what they do, and this pride reflects in the exceptional quality of their work. We strongly recommend Consult Lhasa to anyone seeking expert advice on API degradation profile, drug-excipient compatibility, leachables &amp; extractables, potentially mutagenic and non-mutagenic impurities and most importantly the nitrosamine impurities.&#8221;<\/p>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2397f38 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"2397f38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Muzaffar Khan, Senior General Manager within Regulatory Affairs at Laurus Labs Limited<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-22125ee\" data-id=\"22125ee\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa07a5b elementor-widget elementor-widget-image\" data-id=\"aa07a5b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1080\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan.png\" class=\"attachment-full size-full wp-image-2764\" alt=\"Muzaffar Khan testimonial image\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan.png 1080w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan-1024x1024.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan-768x768.png 768w\" sizes=\"(max-width: 1080px) 100vw, 1080px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"1885\" class=\"elementor elementor-1885 swiper-slide e-loop-item e-loop-item-4206 post-4206 testimonial type-testimonial status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" role=\"group\" aria-roledescription=\"slide\" data-custom-edit-handle=\"1\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7e552b6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7e552b6\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-169dc22\" data-id=\"169dc22\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9839265 elementor-widget elementor-widget-theme-post-content\" data-id=\"9839265\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-content.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p>\u201c<span data-teams=\"true\">We recently had the opportunity to collaborate with Consult Lhasa on the AI\/ limit derivation of a new NDSRI. Given the challenge of limited specific data available for the queried nitrosamine, we sought Consult Lhasa\u2019s expertise to enhance the robustness of our Read-Across approach. Their work is referenced in the latest global regulatory updates on nitrosamines, and this high level of scientific rigor was clearly reflected in their deliverables.<br \/>\nWe sincerely thank the team for their deep scientific knowledge, timely efforts, and outstanding support.<br \/>\nWe highly recommend Consult Lhasa and look forward to another productive collaboration in the future.<\/span>\u201d<\/p>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2397f38 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"2397f38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Eleni Politi, Chemistry, Manufacturing and Controls\/Safety Toxicologist at Rontis Hellas<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-22125ee\" data-id=\"22125ee\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa07a5b elementor-widget elementor-widget-image\" data-id=\"aa07a5b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1080\" height=\"1080\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/09\/Untitled-design-2-e1756990697238.png\" class=\"attachment-full size-full wp-image-4208\" alt=\"Eleni Politi, MSc\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-prev\" role=\"button\" tabindex=\"0\" aria-label=\"Anterior\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-chevron-left\"><\/i>\t\t\t<\/div>\n\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-next\" role=\"button\" tabindex=\"0\" aria-label=\"Siguiente\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-chevron-right\"><\/i>\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4de9f4f elementor-align-center elementor-widget elementor-widget-button\" data-id=\"4de9f4f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.consultlhasa.com\/testimonials\">\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\">View more testimonials<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9c6d713 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9c6d713\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c579562\" data-id=\"c579562\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c3b6913 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"c3b6913\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" d=\"m55.51,63.64L103.25,7.25c2.42-2.86.39-7.25-3.36-7.25H4.41C.66,0-1.37,4.39,1.05,7.25l47.74,56.39c1.76,2.08,4.96,2.08,6.72,0Z\"><\/path><\/g><\/svg><\/div>\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>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1f866f3 elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"1f866f3\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[],&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c5a42b3\" data-id=\"c5a42b3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-77a3b35 elementor-widget elementor-widget-heading\" data-id=\"77a3b35\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Get in touch\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8ff60c7 elementor-widget elementor-widget-text-editor\" data-id=\"8ff60c7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>If you are interested in discovering how Consult Lhasa could improve your potentially mutagenic impurities risk assessments, get in touch.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ec25fa elementor-align-center elementor-widget elementor-widget-button\" data-id=\"2ec25fa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.consultlhasa.com\/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\">Consult an expert<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Potentially mutagenic impurities Supporting your computational assessment and control of potentially mutagenic impurities (PMIs) Get in touch Assessment and control [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":2888,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"content-type":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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