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Non-genotoxic Impurity Assessment | Lhasa Limited
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class="elementor-item menu-link" tabindex="-1">Contact us</a></li> </ul> </nav> </div> </div> </div> </div> </div> </section> </div> <div id="content" class="site-content"> <div class="ast-container"> <div id="primary" class="content-area primary"> <main id="main" class="site-main"> <article class="post-1008 page type-page status-publish ast-article-single" id="post-1008" itemtype="https://schema.org/CreativeWork" itemscope="itemscope"> <header class="entry-header ast-no-title ast-header-without-markup"> </header> <!-- .entry-header --> <div class="entry-content clear" itemprop="text"> <div data-elementor-type="wp-page" data-elementor-id="1008" class="elementor elementor-1008" data-elementor-post-type="page"> <section data-dce-background-overlay-color="#FFFFFF00" data-dce-background-image-url="https://www.lhasalimited.org/wp-content/uploads/2022/11/solutions-banner-v2-scaled.jpg" class="elementor-section elementor-top-section elementor-element elementor-element-7dd007b3 elementor-section-height-min-height elementor-section-items-top elementor-section-boxed elementor-section-height-default" data-id="7dd007b3" data-element_type="section" data-settings="{"background_background":"classic","jet_parallax_layout_list":[]}"> <div class="elementor-background-overlay"></div> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-4aae41d1" data-id="4aae41d1" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-57c879cd elementor-widget elementor-widget-heading" data-id="57c879cd" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">Non-genotoxic impurity assessment</h1> </div> </div> <div class="elementor-element elementor-element-293fc649 elementor-widget elementor-widget-text-editor" data-id="293fc649" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Supporting your non-genotoxic impurity (NGI) qualification</p> </div> </div> <div class="elementor-element elementor-element-ca84644 elementor-widget elementor-widget-button" data-id="ca84644" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/contact-us"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Get in touch</span> </span> </a> </div> </div> </div> </div> </div> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-55dba983" data-id="55dba983" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-34b2832f elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="34b2832f" data-element_type="section" data-settings="{"background_background":"classic","jet_parallax_layout_list":[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5f4a1fb4" data-id="5f4a1fb4" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <section class="elementor-section elementor-inner-section elementor-element elementor-element-5816c194 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="5816c194" data-element_type="section" data-settings="{"jet_parallax_layout_list":[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-635bd75" data-id="635bd75" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-71169f85 elementor-widget elementor-widget-text-editor" data-id="71169f85" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">If your impurity is not mutagenic or carcinogenic, the impurity levels may still need to be justified, to demonstrate that the level of impurity present is safe. Below a threshold, non-genotoxic impurities (NGIs) are accepted but where they are present at a level above the threshold, an impurity qualification is required. NGI qualification requires a weight of evidence assessment, which we can help you with.</span></p> </div> </div> </div> </div> </div> </section> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-383fbca8 elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible" data-id="383fbca8" data-element_type="section" data-settings="{"background_background":"classic","jet_parallax_layout_list":[],"animation":"rotateInUpLeft"}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-67c8f5f0" data-id="67c8f5f0" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-47a84bb elementor-widget elementor-widget-heading" data-id="47a84bb" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Our solution</h2> </div> </div> <div class="elementor-element elementor-element-2dad4adc elementor-widget elementor-widget-text-editor" data-id="2dad4adc" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">We can support you in your toxicity risk assessment of non-genotoxic impurities (NGIs) through our <i>in silico</i> software solutions; Vitic and Derek Nexus. Both Vitic and Derek Nexus go beyond carcinogenicity and genotoxicity, allowing you to assess the broader toxicity of your impurities.</span></p> </div> </div> <section class="elementor-section elementor-inner-section elementor-element elementor-element-778b82a0 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="778b82a0" data-element_type="section" data-settings="{"jet_parallax_layout_list":[],"animation":"none"}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-17f29283" data-id="17f29283" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-624b5295 dce_masking-none elementor-widget elementor-widget-image" data-id="624b5295" data-element_type="widget" data-settings="{"motion_fx_motion_fx_mouse":"yes"}" data-widget_type="image.default"> <div class="elementor-widget-container"> <a href="#Vitic"> <img decoding="async" width="2068" height="769" src="https://www.lhasalimited.org/wp-content/uploads/2022/11/vitic-logo-1.png" class="elementor-animation-hang attachment-full size-full wp-image-2668" alt="vitic logo 1" srcset="https://www.lhasalimited.org/wp-content/uploads/2022/11/vitic-logo-1.png 2068w, https://www.lhasalimited.org/wp-content/uploads/2022/11/vitic-logo-1-300x112.png 300w, https://www.lhasalimited.org/wp-content/uploads/2022/11/vitic-logo-1-1024x381.png 1024w, https://www.lhasalimited.org/wp-content/uploads/2022/11/vitic-logo-1-768x286.png 768w, https://www.lhasalimited.org/wp-content/uploads/2022/11/vitic-logo-1-1536x571.png 1536w, https://www.lhasalimited.org/wp-content/uploads/2022/11/vitic-logo-1-2048x762.png 2048w" sizes="(max-width: 2068px) 100vw, 2068px"> </a> </div> </div> </div> </div> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-60926a7b" data-id="60926a7b" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-57973b61 dce_masking-none elementor-widget elementor-widget-image" data-id="57973b61" data-element_type="widget" data-settings="{"motion_fx_motion_fx_mouse":"yes"}" data-widget_type="image.default"> <div class="elementor-widget-container"> <a href="#Derek"> <img decoding="async" width="1024" height="381" src="https://www.lhasalimited.org/wp-content/uploads/2022/11/derek-logo-1024x381.png" class="elementor-animation-hang attachment-large size-large wp-image-2667" alt="derek logo" srcset="https://www.lhasalimited.org/wp-content/uploads/2022/11/derek-logo-1024x381.png 1024w, https://www.lhasalimited.org/wp-content/uploads/2022/11/derek-logo-300x112.png 300w, https://www.lhasalimited.org/wp-content/uploads/2022/11/derek-logo-768x286.png 768w, https://www.lhasalimited.org/wp-content/uploads/2022/11/derek-logo-1536x571.png 1536w, https://www.lhasalimited.org/wp-content/uploads/2022/11/derek-logo-2048x762.png 2048w" sizes="(max-width: 1024px) 100vw, 1024px"> </a> </div> </div> </div> </div> </div> </section> <div class="elementor-element elementor-element-1cea0c84 elementor-widget elementor-widget-menu-anchor" data-id="1cea0c84" data-element_type="widget" data-widget_type="menu-anchor.default"> <div class="elementor-widget-container"> <div class="elementor-menu-anchor" id="Vitic"></div> </div> </div> </div> </div> </div> </section> <section data-dce-background-color="#FFFFFF" class="elementor-section elementor-top-section elementor-element elementor-element-6ac07a6d elementor-section-full_width elementor-section-height-default elementor-section-height-default" data-id="6ac07a6d" data-element_type="section" data-settings="{"jet_parallax_layout_list":[],"background_background":"gradient"}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-18eee381" data-id="18eee381" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-408ba183" data-id="408ba183" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-7daa0f66 dce_masking-none elementor-widget elementor-widget-image" data-id="7daa0f66" data-element_type="widget" data-widget_type="image.default"> <div class="elementor-widget-container"> <img loading="lazy" decoding="async" width="2463" height="922" src="https://www.lhasalimited.org/wp-content/uploads/2022/11/VITIC_COLOUR_LOGO.png" class="attachment-full size-full wp-image-1578" alt="VITIC COLOUR LOGO" srcset="https://www.lhasalimited.org/wp-content/uploads/2022/11/VITIC_COLOUR_LOGO.png 2463w, https://www.lhasalimited.org/wp-content/uploads/2022/11/VITIC_COLOUR_LOGO-300x112.png 300w, https://www.lhasalimited.org/wp-content/uploads/2022/11/VITIC_COLOUR_LOGO-1024x383.png 1024w, https://www.lhasalimited.org/wp-content/uploads/2022/11/VITIC_COLOUR_LOGO-768x287.png 768w, https://www.lhasalimited.org/wp-content/uploads/2022/11/VITIC_COLOUR_LOGO-1536x575.png 1536w, https://www.lhasalimited.org/wp-content/uploads/2022/11/VITIC_COLOUR_LOGO-2048x767.png 2048w" sizes="(max-width: 2463px) 100vw, 2463px"> </div> </div> <div class="elementor-element elementor-element-701d676c elementor-widget elementor-widget-text-editor" data-id="701d676c" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><b>Vitic </b><span style="font-weight: 400;">is a source of high-quality, peer-reviewed public and proprietary toxicity data, covering a broad range of endpoints. Vitic can help you to understand if there is existing data available for your compound. </span></p> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-c8a80f2" data-id="c8a80f2" data-element_type="column" data-settings="{"background_background":"classic"}"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-7b2add9e elementor-widget elementor-widget-heading" data-id="7b2add9e" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Vitic highlights</h2> </div> </div> <div class="elementor-element elementor-element-2811e2a2 elementor-widget elementor-widget-text-editor" data-id="2811e2a2" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><strong><span style="color: #333f48;"><b>Search for data across a broad range of endpoints </b></span></strong><br /><span style="font-weight: 400;">Vitic is a database that contains toxicity data for endpoints beyond carcinogenicity and genotoxicity – such as acute toxicity, skin sensitisation, irritation and developmental and reproductive toxicity – which can help to assess the broader toxicity of your impurities. </span></p> </div> </div> <div class="elementor-element elementor-element-27359630 elementor-widget elementor-widget-text-editor" data-id="27359630" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="color: #333f48;"><strong><b>Access high-quality public and proprietary data </b></strong><br /></span><span style="font-weight: 400;">The toxicity data held within Vitic comes from a wide variety of sources, Vitic contains expert curated, high-quality and peer-reviewed data, from both published and unpublished sources.</span></p> </div> </div> <div class="elementor-element elementor-element-33ef4d3a elementor-widget elementor-widget-text-editor" data-id="33ef4d3a" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="color: #333f48;"><strong><b>Find similar structural analogues using substructure or similarity searches</b></strong><br /></span><span style="font-weight: 400;">Where there is no exact match within Vitic, you can make use of the substructure or similarity search functionality.</span></p><p> </p> </div> </div> <div class="elementor-element elementor-element-962d780 elementor-align-left elementor-widget elementor-widget-button" data-id="962d780" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/contact-us"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Get in touch</span> </span> </a> </div> </div> </div> <div class="elementor-element elementor-element-7bad4ddd elementor-widget elementor-widget-menu-anchor" data-id="7bad4ddd" data-element_type="widget" data-widget_type="menu-anchor.default"> <div class="elementor-widget-container"> <div class="elementor-menu-anchor" id="Derek"></div> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-560d60b" data-id="560d60b" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-4f633b17 elementor-section-full_width elementor-section-height-default elementor-section-height-default" data-id="4f633b17" data-element_type="section" data-settings="{"jet_parallax_layout_list":[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-63acbe17" data-id="63acbe17" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-aa97e53" data-id="aa97e53" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-68f4673 dce_masking-none elementor-widget elementor-widget-image" data-id="68f4673" data-element_type="widget" data-widget_type="image.default"> <div class="elementor-widget-container"> <img loading="lazy" decoding="async" width="2382" height="810" src="https://www.lhasalimited.org/wp-content/uploads/2022/11/DEREK_LOGO.png" class="attachment-full size-full wp-image-1556" alt="DEREK LOGO" srcset="https://www.lhasalimited.org/wp-content/uploads/2022/11/DEREK_LOGO.png 2382w, https://www.lhasalimited.org/wp-content/uploads/2022/11/DEREK_LOGO-300x102.png 300w, https://www.lhasalimited.org/wp-content/uploads/2022/11/DEREK_LOGO-1024x348.png 1024w, https://www.lhasalimited.org/wp-content/uploads/2022/11/DEREK_LOGO-768x261.png 768w, https://www.lhasalimited.org/wp-content/uploads/2022/11/DEREK_LOGO-1536x522.png 1536w, https://www.lhasalimited.org/wp-content/uploads/2022/11/DEREK_LOGO-2048x696.png 2048w" sizes="(max-width: 2382px) 100vw, 2382px"> </div> </div> <div class="elementor-element elementor-element-64692fdb elementor-widget elementor-widget-text-editor" data-id="64692fdb" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><strong>Derek Nexus</strong> is an expert, knowledge-based prediction software that can help you to establish if there is a toxicity hazard associated with your compound.</p> </div> </div> </div> </div> <div data-dce-background-overlay-color="#FFFFFF" class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-309a454e" data-id="309a454e" data-element_type="column" data-settings="{"background_background":"classic"}"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-background-overlay"></div> <div class="elementor-element elementor-element-553c6fbf elementor-widget elementor-widget-heading" data-id="553c6fbf" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Derek Nexus highlights</h2> </div> </div> <div class="elementor-element elementor-element-77ed2510 elementor-widget elementor-widget-text-editor" data-id="77ed2510" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><strong><span style="color: #333f48;"><b>Access expert Structure-Activity Relationship (SAR) knowledge for over 70 endpoints </b></span></strong><br><span style="font-weight: 400;">Derek Nexus contains Structure-Activity Relationship (SAR) knowledge for a broad range of endpoints – including acute toxicity, skin sensitisation, irritation and developmental and reproductive toxicity, and more. The SAR knowledge is derived from both public and proprietary member data sources and is updated as new data becomes available.</span></p> </div> </div> <div class="elementor-element elementor-element-5510d162 elementor-widget elementor-widget-text-editor" data-id="5510d162" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><strong><span style="color: #333f48;"><b>Identify any toxicophores highlighting possible hazard </b></span></strong><br /><span style="font-weight: 400;">The expert comments associated with a Derek Nexus alert can help you to decide if this compound structure is a concern or not. </span></p> </div> </div> <div class="elementor-element elementor-element-42fe937a elementor-widget elementor-widget-text-editor" data-id="42fe937a" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><strong><span style="color: #333f48;"><b>Understand the SAR behind predictions </b></span></strong><br /><span style="font-weight: 400;">The scientific comments which accompany a Derek Nexus alert will describe the chemical and biological mechanisms of action where possible. </span></p> </div> </div> <div class="elementor-element elementor-element-46775aa5 elementor-align-left elementor-widget elementor-widget-button" data-id="46775aa5" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/contact-us"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Get in touch</span> </span> </a> </div> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-36f5402b" data-id="36f5402b" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-6f906cf elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="6f906cf" data-element_type="section" data-settings="{"jet_parallax_layout_list":[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f55f11" data-id="f55f11" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-550ba52a elementor-widget elementor-widget-heading" data-id="550ba52a" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Regulatory support</h2> </div> </div> <div class="elementor-element elementor-element-80fa9b0 elementor-widget elementor-widget-text-editor" data-id="80fa9b0" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">Vitic and Derek Nexus can help you with the qualification of impurities from your API or drug product, to determine whether any additional studies are necessary, in relation to the below relevant guidance.</span></p> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-965f5e4 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="965f5e4" data-element_type="section" data-settings="{"jet_parallax_layout_list":[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-688b97c" data-id="688b97c" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div 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elementor-widget-heading" data-id="725465a" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">ICH Q3A</h2> </div> </div> <div class="elementor-element elementor-element-a95013b elementor-widget elementor-widget-text-editor" data-id="a95013b" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>The <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q3ar-impurities-new-drug-substances" target="_blank" rel="noopener">ICH Q3A</a> (Impurities in New Drug Substances) guideline provides guidance on the qualification of new drug substances produced by chemical synthesis.</p> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-b32fe55 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="b32fe55" data-element_type="section" data-settings="{"jet_parallax_layout_list":[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-af44c70" data-id="af44c70" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-d5c4ac4 elementor-view-default elementor-widget elementor-widget-icon" data-id="d5c4ac4" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" id="Layer_1" viewBox="0 0 408.85 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class="cls-4" d="M156.14,168.54c31.4,0,62.81-.03,94.21,.02,9.37,.01,15.35,7.7,12.43,15.86-1.74,4.86-5.36,7.45-10.43,8.01-1.32,.15-2.66,.07-3.99,.07-61.74,0-123.48,0-185.22,0-9.58,0-15.15-4.41-15.15-11.98,0-7.57,5.57-11.98,15.15-11.98,31,0,62.01,0,93.01,0Z"></path><path class="cls-2" d="M133.78,240.41c-24.34,0-48.67,.05-73.01-.03-9.21-.03-15.11-8.1-11.97-16.17,1.74-4.48,5.16-6.97,9.88-7.65,1.05-.15,2.12-.1,3.19-.1,48.14,0,96.28,0,144.42,0,6.84,0,11.48,2.92,13.19,8.19,2.58,7.97-3.11,15.66-11.88,15.73-15.03,.12-30.05,.03-45.08,.04-9.57,0-19.15,0-28.72,0Z"></path><path class="cls-3" d="M203.42,96.66c-15.7,0-31.4,.02-47.1,0-5.29,0-9.27-2.35-11.47-7.17-2-4.37-1.66-9,1.82-12.21,2.44-2.24,6.14-4.34,9.3-4.37,31.8-.32,63.6-.24,95.4-.15,6.91,.02,12.03,5.22,12.13,11.75,.1,6.69-5.1,12.05-12.18,12.1-15.97,.12-31.93,.04-47.9,.04Z"></path><path class="cls-6" d="M203.94,120.63c15.7,0,31.4-.09,47.1,.04,9.09,.07,14.94,8.53,11.51,16.49-2.17,5.03-6.25,7.42-11.7,7.42-13.04,.01-26.08,0-39.12,0-18.36,0-36.72,.06-55.08-.03-9.39-.04-15.41-8.4-11.91-16.5,2.25-5.2,6.49-7.45,12.1-7.44,15.7,.04,31.4,.01,47.1,.01Z"></path><path class="cls-5" d="M300.27,333.02c7.91-8.36,14.75-15.78,21.8-23,5.94-6.09,11.98-12.1,18.19-17.9,7.21-6.74,17.75-3.92,20.24,5.25,1.19,4.38,0,8.28-3.11,11.37-16.24,16.1-32.5,32.19-48.93,48.09-4.94,4.79-11.44,4.66-16.53-.09-8.36-7.8-16.57-15.76-24.65-23.85-4.97-4.98-4.97-12.01-.42-16.85,4.5-4.79,11.53-5.04,16.85-.43,2.81,2.43,5.47,5.06,8.04,7.75,2.57,2.69,4.94,5.58,8.53,9.67Z"></path></svg> </div> </div> </div> </div> </div> </div> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-ab1a731" data-id="ab1a731" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-e9dcd77 elementor-widget elementor-widget-heading" data-id="e9dcd77" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">ICH Q3B</h2> </div> </div> <div class="elementor-element elementor-element-caf37d9 elementor-widget elementor-widget-text-editor" data-id="caf37d9" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>The <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q3br-impurities-new-drug-products-revision-3" target="_blank" rel="noopener">ICH Q3B</a> (Impurities in New Drug Products) guideline provides guidance on the qualification of impurities in new drug products</p> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-8822a28 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="8822a28" data-element_type="section" data-settings="{"jet_parallax_layout_list":[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-74d1144" data-id="74d1144" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-b13ee02 elementor-view-default elementor-widget elementor-widget-icon" data-id="b13ee02" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" id="Layer_1" viewBox="0 0 408.85 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</div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-3ee9436 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="3ee9436" data-element_type="section" data-settings="{"jet_parallax_layout_list":[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-d227c64" data-id="d227c64" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-9c24236 elementor-widget elementor-widget-text-editor" data-id="9c24236" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>© 2024 Lhasa Limited, All rights reserved | Company registration number: 01765239 | <br />VAT number: 396 8737 77 | Registered charity number: 290866 | <a href="https://www.lhasalimited.org/governing-documents/">Governing documents</a></p> </div> </div> </div> </div> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-643e93e" data-id="643e93e" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-2374aba elementor-widget__width-initial elementor-widget elementor-widget-shortcode" data-id="2374aba" data-element_type="widget" data-widget_type="shortcode.default"> <div class="elementor-widget-container"> <div class="elementor-shortcode"><div id="google_language_translator" class="default-language-en"></div></div> </div> </div> <div class="elementor-element elementor-element-412436c elementor-widget__width-auto elementor-widget elementor-widget-heading" data-id="412436c" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 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