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Nitrites | Lhasa Limited
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data-elementor-type="wp-page" data-elementor-id="926" class="elementor elementor-926" 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-516cc01e elementor-section-height-min-height elementor-section-items-top elementor-section-boxed elementor-section-height-default" data-id="516cc01e" 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-71675c34" data-id="71675c34" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-3c49119 elementor-widget elementor-widget-heading" data-id="3c49119" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">Nitrites</h1> </div> </div> <div class="elementor-element elementor-element-741bb36e elementor-widget elementor-widget-text-editor" data-id="741bb36e" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Assessing the levels of nitrites in pharmaceutical excipients, solvents and reagents</p> </div> </div> <div class="elementor-element elementor-element-6d93603f elementor-widget elementor-widget-button" data-id="6d93603f" 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-49590402" data-id="49590402" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-344e673b elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="344e673b" 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-7d4b531" data-id="7d4b531" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <section class="elementor-section elementor-inner-section elementor-element elementor-element-129014f1 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="129014f1" 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-780cb92a" data-id="780cb92a" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-770969c1 elementor-widget elementor-widget-text-editor" data-id="770969c1" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">The presence of <em>N</em>-Nitrosamines in drug products continues to be a global concern. The presence of nitrites in formulations and understanding the potential contribution they may have on the formation of nitrosamines in final drug products is a crucial part of nitrosamine impurity assessment.</span></p><p><span style="font-weight: 400;">The Nitrites data sharing initiative forms part of our efforts to support the global challenge of nitrosamine impurity assessment. The initiative supports more scientifically driven risk assessments, aiding data sharing among pharmaceutical companies and enabling more informed decision making.</span></p> </div> </div> </div> </div> </div> </section> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-2948334 elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible" data-id="2948334" 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-1049d54" data-id="1049d54" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-0a2a846 elementor-widget elementor-widget-heading" data-id="0a2a846" 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-6baa3606 elementor-widget elementor-widget-text-editor" data-id="6baa3606" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">The Nitrites data sharing initiative has established a consortium. By sharing data on the level of nitrites in common excipients, solvents and reagents, consortium members can assess the variability and likelihood that a nitrate will react to form a nitrosamine.</span></p> </div> </div> <section class="elementor-section elementor-inner-section elementor-element elementor-element-cf9411f elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="cf9411f" 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-33 elementor-inner-column elementor-element elementor-element-a2052aa" data-id="a2052aa" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> <div class="elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-0605c8d" data-id="0605c8d" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-2aa34e70 dce_masking-none elementor-widget elementor-widget-image" data-id="2aa34e70" 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="1430" height="534" src="https://www.lhasalimited.org/wp-content/uploads/2023/02/VITIC_Nitrites_LOGOS.png" class="elementor-animation-hang attachment-full size-full wp-image-6752" alt="VITIC Nitrites LOGOS" srcset="https://www.lhasalimited.org/wp-content/uploads/2023/02/VITIC_Nitrites_LOGOS.png 1430w, https://www.lhasalimited.org/wp-content/uploads/2023/02/VITIC_Nitrites_LOGOS-300x112.png 300w, https://www.lhasalimited.org/wp-content/uploads/2023/02/VITIC_Nitrites_LOGOS-1024x382.png 1024w, https://www.lhasalimited.org/wp-content/uploads/2023/02/VITIC_Nitrites_LOGOS-768x287.png 768w" sizes="(max-width: 1430px) 100vw, 1430px"> </a> </div> </div> </div> </div> <div class="elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-f669e33" data-id="f669e33" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> </div> </section> <div class="elementor-element elementor-element-8b8407d elementor-widget elementor-widget-text-editor" data-id="8b8407d" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">The Nitrites database acts as a central platform to hold the data donated by pharmaceutical organisation members on the levels of nitrites in pharmaceutical drug products.</span></p><p><span style="font-weight: 400;">Used in this way, the Nitrites database allows members to understand the risk posed and aid in complying nitrosamines risk assessments in the drug product.</span></p> </div> </div> <div class="elementor-element elementor-element-f133d0e elementor-widget elementor-widget-menu-anchor" data-id="f133d0e" 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-0c99de1 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="0c99de1" 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-100 elementor-top-column elementor-element elementor-element-e770ec3" data-id="e770ec3" data-element_type="column" data-settings="{"background_background":"classic"}"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-1a0be5b elementor-widget elementor-widget-heading" data-id="1a0be5b" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Key highlights</h2> </div> </div> <div class="elementor-element elementor-element-8849166 elementor-widget elementor-widget-text-editor" data-id="8849166" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><strong><span style="color: #333f48;"><b>Access high-quality data</b></span></strong><br /><span style="font-weight: 400;">Data quality is crucial to the success of the initiative; data can be generated using any analytical method, provided the validation against the consortium criteria is met. This process guarantees a high-quality dataset that you can be confident using.</span></p> </div> </div> <div class="elementor-element elementor-element-33be9430 elementor-widget elementor-widget-text-editor" data-id="33be9430" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><b>Enhance your risk assessment workflow<br /></b><span style="font-weight: 400;">Expand your knowledge of nitrite levels present in a wide range of products using proprietary data. In addition, minimise the need to carry out drug product testing and streamline your workflow by using data to support multiple risk assessments.</span></p> </div> </div> <div class="elementor-element elementor-element-d77eb7f elementor-widget elementor-widget-text-editor" data-id="d77eb7f" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><b>Collaborate within industry</b><span style="font-weight: 400;"><br /></span><span style="font-weight: 400;">Joining the initiative also means collaborating in an industry consortium that meet regularly to discuss this topic. Work with experts on this shared challenge and discuss and agree upon the scientific direction of the initiative.</span></p> </div> </div> <div class="elementor-element elementor-element-2fee335 elementor-align-left elementor-widget elementor-widget-button" data-id="2fee335" 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> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-4a050f04 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="4a050f04" 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-a506fb3" data-id="a506fb3" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-24e7aacb elementor-widget elementor-widget-heading" data-id="24e7aacb" 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-3b84052 elementor-position-left elementor-view-default elementor-mobile-position-top elementor-vertical-align-top elementor-widget elementor-widget-icon-box" data-id="3b84052" data-element_type="widget" data-widget_type="icon-box.default"> <div class="elementor-widget-container"> <div class="elementor-icon-box-wrapper"> <div class="elementor-icon-box-icon"> <span 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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> </span> </div> <div class="elementor-icon-box-content"> <p class="elementor-icon-box-description"> Together with the industry-based consortium, we are familiarising the database with multiple regulatory authorities to share the work being carried out and the knowledge being developed. We aim to make both industry and regulators aware of this important data sharing initiative so that we can continue to positively impact the industry with shared knowledge. Join our Nitrites data sharing initiative and become part of a thought leading consortium! </p> </div> </div> </div> </div> <div class="elementor-element elementor-element-39a03afd elementor-align-center elementor-widget elementor-widget-button" data-id="39a03afd" 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> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-1c46160 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="1c46160" data-element_type="section" data-settings="{"jet_parallax_layout_list":[],"background_background":"classic"}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-82112ee" data-id="82112ee" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-6738e52 elementor-widget elementor-widget-heading" data-id="6738e52" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Related publications</h2> </div> </div> <div class="elementor-element elementor-element-5072c79 premium-cursor-icon premium-gbadge-stripe premium-gbadge-row premium-gbadge-right premium-gbadge-top elementor-widget elementor-widget-jet-listing-grid" data-id="5072c79" data-element_type="widget" data-settings="{"columns":"1"}" data-widget_type="jet-listing-grid.default"> <div class="elementor-widget-container"> <div class="jet-listing-grid jet-listing"><div class="jet-listing-grid__items grid-col-desk-1 grid-col-tablet-1 grid-col-mobile-1 jet-listing-grid--5755" data-queried-id="926|WP_Post" data-nav="{"enabled":false,"type":null,"more_el":null,"query":[],"widget_settings":{"lisitng_id":5755,"posts_num":3,"columns":1,"columns_tablet":1,"columns_mobile":1,"is_archive_template":"","post_status":["publish"],"use_random_posts_num":"","max_posts_num":9,"not_found_message":"No data was found","is_masonry":false,"equal_columns_height":"","use_load_more":"","load_more_id":"","load_more_type":"click","load_more_offset":{"unit":"px","size":0,"sizes":[]},"use_custom_post_types":"","custom_post_types":[],"hide_widget_if":"","carousel_enabled":"","slides_to_scroll":"1","arrows":"true","arrow_icon":"fa 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data-element_type="section" data-settings="{"jet_parallax_layout_list":[],"background_background":"classic"}"> <div class="elementor-container elementor-column-gap-default"> <div class="make-column-clickable-elementor elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4222da16" style="cursor: pointer;" data-column-clickable="https://www.lhasalimited.org/publications/lhasa-limited-and-international-pharmaceutical-excipients-council-europe-collaborative-meeting-report/" data-column-clickable-blank="_self" data-id="4222da16" data-element_type="column" data-settings="{"background_background":"classic"}"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-3181d5ac elementor-widget elementor-widget-heading" data-id="3181d5ac" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default"><a href="https://www.lhasalimited.org/publications/lhasa-limited-and-international-pharmaceutical-excipients-council-europe-collaborative-meeting-report/">Lhasa Limited and International Pharmaceutical Excipients Council Europe collaborative meeting report</a></p> </div> </div> <div class="elementor-element elementor-element-570e2eb6 elementor-icon-list--layout-inline elementor-align-left elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="570e2eb6" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items elementor-inline-items"> <li class="elementor-icon-list-item elementor-inline-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="far fa-calendar-alt"></i> </span> <span class="elementor-icon-list-text">May 2024</span> </li> <li class="elementor-icon-list-item elementor-inline-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-tv"></i> </span> <span class="elementor-icon-list-text"><span>Data sharing</span>, <span>Nitrites</span></span> </li> </ul> </div> </div> </div> </div> </div> </section> </div> </div><div class="jet-listing-grid__item jet-listing-dynamic-post-5683" data-post-id="5683" > <div data-elementor-type="jet-listing-items" data-elementor-id="5755" class="elementor elementor-5755" data-elementor-post-type="jet-engine"> <section class="elementor-section elementor-top-section elementor-element elementor-element-1bd7f055 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="1bd7f055" data-element_type="section" data-settings="{"jet_parallax_layout_list":[],"background_background":"classic"}"> <div class="elementor-container elementor-column-gap-default"> <div class="make-column-clickable-elementor elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4222da16" style="cursor: pointer;" data-column-clickable="https://www.lhasalimited.org/publications/the-landscape-of-potential-small-and-drug-substance-related-nitrosamines-in-pharmaceuticals/" data-column-clickable-blank="_self" data-id="4222da16" data-element_type="column" data-settings="{"background_background":"classic"}"> <div class="elementor-widget-wrap elementor-element-populated"> <div data-dce-advanced-background-color="#14B5E1" class="elementor-element elementor-element-cc2be11 elementor-widget__width-initial elementor-absolute elementor-widget elementor-widget-heading" data-id="cc2be11" data-element_type="widget" data-settings="{"_position":"absolute"}" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-small">Paper</p> </div> </div> <div class="elementor-element elementor-element-3181d5ac elementor-widget elementor-widget-heading" data-id="3181d5ac" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default"><a href="https://www.lhasalimited.org/publications/the-landscape-of-potential-small-and-drug-substance-related-nitrosamines-in-pharmaceuticals/">The Landscape of Potential Small and Drug Substance Related Nitrosamines in Pharmaceuticals</a></p> </div> </div> <div class="elementor-element elementor-element-570e2eb6 elementor-icon-list--layout-inline elementor-align-left elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="570e2eb6" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items elementor-inline-items"> <li class="elementor-icon-list-item elementor-inline-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="far fa-calendar-alt"></i> </span> <span class="elementor-icon-list-text">Nov 2022</span> </li> <li class="elementor-icon-list-item elementor-inline-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-tv"></i> </span> <span class="elementor-icon-list-text"><span>Complex Nitrosamines</span>, <span>Data sharing</span>, <span>In silico mutagenicity assessment</span>, <span>Nitrites</span>, <span>Nitrosamine impurity risk assessment</span></span> </li> </ul> </div> </div> </div> </div> </div> </section> </div> </div><div class="jet-listing-grid__item jet-listing-dynamic-post-5360" data-post-id="5360" > <div data-elementor-type="jet-listing-items" data-elementor-id="5755" class="elementor elementor-5755" data-elementor-post-type="jet-engine"> <section class="elementor-section elementor-top-section elementor-element elementor-element-1bd7f055 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="1bd7f055" data-element_type="section" data-settings="{"jet_parallax_layout_list":[],"background_background":"classic"}"> <div class="elementor-container elementor-column-gap-default"> <div class="make-column-clickable-elementor elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4222da16" style="cursor: pointer;" data-column-clickable="https://www.lhasalimited.org/publications/letter-to-the-editor-of-heliyon-re-determination-of-dimethylamine-and-nitrite-in-pharmaceuticals-by-ion-chromatography-to-assess-the-likelihood-of-nitrosamine-formation/" data-column-clickable-blank="_self" data-id="4222da16" data-element_type="column" data-settings="{"background_background":"classic"}"> <div class="elementor-widget-wrap elementor-element-populated"> <div data-dce-advanced-background-color="#14B5E1" class="elementor-element elementor-element-cc2be11 elementor-widget__width-initial elementor-absolute elementor-widget elementor-widget-heading" data-id="cc2be11" data-element_type="widget" data-settings="{"_position":"absolute"}" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-small">Paper</p> </div> </div> <div class="elementor-element elementor-element-3181d5ac elementor-widget elementor-widget-heading" data-id="3181d5ac" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default"><a href="https://www.lhasalimited.org/publications/letter-to-the-editor-of-heliyon-re-determination-of-dimethylamine-and-nitrite-in-pharmaceuticals-by-ion-chromatography-to-assess-the-likelihood-of-nitrosamine-formation/">Letter to the editor of Heliyon re: determination of dimethylamine and nitrite in pharmaceuticals by ion chromatography to assess the likelihood of nitrosamine formation </a></p> </div> </div> <div class="elementor-element elementor-element-570e2eb6 elementor-icon-list--layout-inline elementor-align-left elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="570e2eb6" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items elementor-inline-items"> <li class="elementor-icon-list-item elementor-inline-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="far fa-calendar-alt"></i> </span> <span class="elementor-icon-list-text">Jun 2022</span> </li> <li class="elementor-icon-list-item elementor-inline-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-tv"></i> </span> <span class="elementor-icon-list-text"><span>Data sharing</span>, <span>Nitrites</span>, <span>Nitrosamine impurity risk assessment</span></span> </li> </ul> </div> </div> </div> </div> </div> </section> </div> </div></div></div> </div> </div> <div class="elementor-element elementor-element-74b3623 elementor-align-center elementor-widget elementor-widget-button" data-id="74b3623" data-element_type="widget" data-widget_type="button.default"> <div 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However, a frequently overlooked issue …</p> </div> <div class="premium-blog-entry-meta"> </div> </div> </div> </div> <div class="premium-blog-post-outer-container" data-total="29"> <div class="premium-blog-post-container premium-blog-skin-cards"> <div class="premium-blog-thumb-effect-wrapper"> <div class="premium-blog-thumbnail-container premium-blog-none-effect"> <a href="https://www.lhasalimited.org/blog/n-nitrosamine-data-support-alternative-ai-beyond-cpca/" target="_self"> <img loading="lazy" decoding="async" width="1200" height="627" src="https://www.lhasalimited.org/wp-content/uploads/2025/01/N-nitrosamine-CPCA-Blog-Image-_-Jan-2025.png" class="attachment-full size-full wp-image-12230" alt="Where can N-Nitrosamine data support an alternative AI beyond the CPCA?" srcset="https://www.lhasalimited.org/wp-content/uploads/2025/01/N-nitrosamine-CPCA-Blog-Image-_-Jan-2025.png 1200w, https://www.lhasalimited.org/wp-content/uploads/2025/01/N-nitrosamine-CPCA-Blog-Image-_-Jan-2025-300x157.png 300w, https://www.lhasalimited.org/wp-content/uploads/2025/01/N-nitrosamine-CPCA-Blog-Image-_-Jan-2025-1024x535.png 1024w, https://www.lhasalimited.org/wp-content/uploads/2025/01/N-nitrosamine-CPCA-Blog-Image-_-Jan-2025-768x401.png 768w" sizes="(max-width: 1200px) 100vw, 1200px" /> </a> </div> <div class="premium-blog-effect-container premium-blog-none-effect"> <a class="premium-blog-post-link" href="https://www.lhasalimited.org/blog/n-nitrosamine-data-support-alternative-ai-beyond-cpca/" target="_self"><span>Where can N-Nitrosamine data support an alternative AI beyond the CPCA?</span></a> </div> </div> <div class="premium-blog-content-wrapper "> <div class="premium-blog-inner-container"> <h2 class="premium-blog-entry-title"> <a href="https://www.lhasalimited.org/blog/n-nitrosamine-data-support-alternative-ai-beyond-cpca/" target="_self"> Where can N-Nitrosamine data support an alternative AI beyond the CPCA? </a> </h2> </div> <div class="premium-blog-content-inner-wrapper"> <p class="premium-blog-post-content">The recently published paper “Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust …</p> </div> <div class="premium-blog-entry-meta"> </div> </div> </div> </div> <div class="premium-blog-post-outer-container" data-total="29"> <div class="premium-blog-post-container premium-blog-skin-cards"> <div class="premium-blog-thumb-effect-wrapper"> <div class="premium-blog-thumbnail-container premium-blog-none-effect"> <a href="https://www.lhasalimited.org/blog/celebrating-our-top-publications-of-2024/" target="_self"> <img loading="lazy" decoding="async" width="1080" height="864" src="https://www.lhasalimited.org/wp-content/uploads/2024/12/2024-Lhasa-Publication-Awards.jpg" class="attachment-full size-full wp-image-12079" alt="2024 Lhasa Publication Award Winners" 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excellence, our top publications of 2024 </a> </h2> </div> <div class="premium-blog-content-inner-wrapper"> <p class="premium-blog-post-content">We recently invited our scientific community to vote for their favourite Lhasa 2024 publication across 3 categories: Toxicology (excluding nitrosamines), Toxicology (specifically …</p> </div> <div class="premium-blog-entry-meta"> </div> </div> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-772a08a elementor-align-center elementor-widget elementor-widget-button" data-id="772a08a" 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="https://www.lhasalimited.org/blog/"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">View all blogs</span> </span> </a> </div> </div> </div> </div> </div> </div> </section> </div> 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wp-image-487" alt="Lhasa Logo" srcset="https://www.lhasalimited.org/wp-content/uploads/2022/09/Lhasa-full-colour-pantone-logo.png 1325w, https://www.lhasalimited.org/wp-content/uploads/2022/09/Lhasa-full-colour-pantone-logo-300x144.png 300w, https://www.lhasalimited.org/wp-content/uploads/2022/09/Lhasa-full-colour-pantone-logo-1024x490.png 1024w, https://www.lhasalimited.org/wp-content/uploads/2022/09/Lhasa-full-colour-pantone-logo-768x367.png 768w" sizes="(max-width: 1325px) 100vw, 1325px" /> </a> </div> </div> <div class="elementor-element elementor-element-1416cfb elementor-widget elementor-widget-text-editor" data-id="1416cfb" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK <br /><strong>Tel: +44 (0)113 394 6020</strong></p> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-1664408" data-id="1664408" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-4522947 elementor-nav-menu__align-start elementor-nav-menu--dropdown-none elementor-widget elementor-widget-nav-menu" data-id="4522947" data-element_type="widget" data-settings="{"layout":"vertical","submenu_icon":{"value":"<i class=\"fas fa-caret-down\"><\/i>","library":"fa-solid"}}" data-widget_type="nav-menu.default"> <div class="elementor-widget-container"> <nav aria-label="Menu" class="elementor-nav-menu--main elementor-nav-menu__container elementor-nav-menu--layout-vertical e--pointer-none"> <ul id="menu-1-4522947" class="elementor-nav-menu sm-vertical"><li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-7380"><a href="https://www.lhasalimited.org/solutions/" class="elementor-item menu-link">Solutions</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page current-page-ancestor 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elementor-nav-menu__container elementor-nav-menu--layout-vertical e--pointer-none"> <ul id="menu-1-89be1a0" class="elementor-nav-menu sm-vertical"><li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-7386"><a href="https://www.lhasalimited.org/careers/" class="elementor-item menu-link">Careers</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-7387"><a href="https://www.lhasalimited.org/our-story/" class="elementor-item menu-link">Our story</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-7388"><a href="https://www.lhasalimited.org/our-members/" class="elementor-item menu-link">Our members</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-7389"><a href="https://www.lhasalimited.org/contact-us/" class="elementor-item menu-link">Contact us</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-7390"><a 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<div class="elementor-element elementor-element-5c6666a elementor-widget elementor-widget-heading" data-id="5c6666a" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Sign up to our newsletter</h2> </div> </div> <div class="elementor-element elementor-element-b622827 eael-gravity-form-button-full-width elementor-widget elementor-widget-eael-gravity-form" data-id="b622827" data-element_type="widget" data-widget_type="eael-gravity-form.default"> <div class="elementor-widget-container"> <div class="eael-contact-form eael-gravity-form labels-hide eael-contact-form-align-default"> <script type="text/javascript"></script> <div class='gf_browser_ie gf_browser_ie7 gform_wrapper gravity-theme gform-theme--no-framework' data-form-theme='gravity-theme' data-form-index='0' id='gform_wrapper_8' ><form method='post' enctype='multipart/form-data' id='gform_8' action='/data-sharing/nitrites/' data-formid='8' novalidate> <div class='gform-body gform_body'><div id='gform_fields_8' class='gform_fields top_label form_sublabel_below description_below validation_below'><fieldset id="field_8_4" class="gfield gfield--type-name gfield--input-type-name gfield--width-full gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible" data-js-reload="field_8_4" ><legend class='gfield_label gform-field-label gfield_label_before_complex' >Name<span class="gfield_required"><span class="gfield_required gfield_required_text">(Required)</span></span></legend><div class='ginput_complex ginput_container ginput_container--name no_prefix has_first_name no_middle_name has_last_name no_suffix gf_name_has_2 ginput_container_name gform-grid-row' id='input_8_4'> <span id='input_8_4_3_container' class='name_first gform-grid-col gform-grid-col--size-auto' > <input type='text' name='input_4.3' id='input_8_4_3' value='' aria-required='true' placeholder='First name' /> <label for='input_8_4_3' class='gform-field-label gform-field-label--type-sub '>First</label> </span> <span id='input_8_4_6_container' class='name_last gform-grid-col gform-grid-col--size-auto' > <input type='text' name='input_4.6' id='input_8_4_6' value='' aria-required='true' placeholder='Last name' /> <label for='input_8_4_6' class='gform-field-label gform-field-label--type-sub '>Last</label> </span> </div></fieldset><div id="field_8_5" class="gfield gfield--type-email gfield--input-type-email gfield--width-full gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible" data-js-reload="field_8_5" ><label class='gfield_label gform-field-label' for='input_8_5'>Email<span class="gfield_required"><span class="gfield_required gfield_required_text">(Required)</span></span></label><div class='ginput_container ginput_container_email'> <input name='input_5' id='input_8_5' type='email' value='' class='large' placeholder='Business email address' aria-required="true" aria-invalid="false" /> </div></div><div id="field_8_7" class="gfield gfield--type-text gfield--input-type-text gfield--width-full gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible" data-js-reload="field_8_7" ><label class='gfield_label gform-field-label' for='input_8_7'>What country are you based in?<span class="gfield_required"><span class="gfield_required gfield_required_text">(Required)</span></span></label><div class='ginput_container ginput_container_text'><input name='input_7' id='input_8_7' type='text' value='' class='large' placeholder='What country are you based in?' aria-required="true" aria-invalid="false" /></div></div><div id="field_8_6" class="gfield gfield--type-hidden gfield--input-type-hidden gfield--width-full gform_hidden field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible" data-js-reload="field_8_6" ><div class='ginput_container ginput_container_text'><input name='input_6' id='input_8_6' type='hidden' class='gform_hidden' aria-invalid="false" value='' /></div></div><div id="field_8_24" class="gfield gfield--type-hidden gfield--input-type-hidden gfield--width-full gform_hidden field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible" data-js-reload="field_8_24" ><div class='ginput_container ginput_container_text'><input name='input_24' id='input_8_24' type='hidden' class='gform_hidden' aria-invalid="false" value='Opt-in New Contact' /></div></div><div id="field_8_8" class="gfield gfield--type-hidden gfield--input-type-hidden gfield--width-full gform_hidden field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible" data-js-reload="field_8_8" ><div class='ginput_container ginput_container_text'><input name='input_8' id='input_8_8' type='hidden' class='gform_hidden' aria-invalid="false" value='Unknown/Event Registration' /></div></div><fieldset id="field_8_11" class="gfield gfield--type-checkbox gfield--type-choice gfield--input-type-checkbox gfield--width-full field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_hidden" data-js-reload="field_8_11" ><div class="admin-hidden-markup"><i class="gform-icon gform-icon--hidden" aria-hidden="true" title="This field is hidden when viewing the form"></i><span>This field is hidden when viewing the form</span></div><legend class='gfield_label gform-field-label gfield_label_before_complex' >GDPR Compliant</legend><div class='ginput_container ginput_container_checkbox'><div class='gfield_checkbox ' id='input_8_11'><div class='gchoice gchoice_8_11_1'> <input class='gfield-choice-input' name='input_11.1' type='checkbox' value='Yes' checked='checked' id='choice_8_11_1' /> <label for='choice_8_11_1' id='label_8_11_1' class='gform-field-label gform-field-label--type-inline'>Yes</label> </div></div></div></fieldset><div id="field_8_17" class="gfield gfield--type-select gfield--input-type-select gfield--width-full field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_hidden" data-js-reload="field_8_17" ><div class="admin-hidden-markup"><i class="gform-icon gform-icon--hidden" aria-hidden="true" title="This field is hidden when viewing the form"></i><span>This field is hidden when viewing the form</span></div><label class='gfield_label gform-field-label' for='input_8_17'>Publications</label><div class='ginput_container ginput_container_select'><select name='input_17' id='input_8_17' class='large gfield_select' aria-invalid="false" ><option value='True' selected='selected'>True</option></select></div></div><div id="field_8_18" class="gfield gfield--type-select gfield--input-type-select gfield--width-full field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_hidden" data-js-reload="field_8_18" ><div class="admin-hidden-markup"><i class="gform-icon gform-icon--hidden" aria-hidden="true" title="This field is hidden when viewing the form"></i><span>This field is hidden when viewing the form</span></div><label class='gfield_label gform-field-label' for='input_8_18'>Upcoming Events</label><div class='ginput_container ginput_container_select'><select name='input_18' id='input_8_18' class='large gfield_select' aria-invalid="false" ><option value='True' selected='selected'>True</option></select></div></div><div id="field_8_20" class="gfield gfield--type-select gfield--input-type-select gfield--width-full field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_hidden" data-js-reload="field_8_20" ><div class="admin-hidden-markup"><i class="gform-icon gform-icon--hidden" aria-hidden="true" title="This field is hidden when viewing the form"></i><span>This field is hidden when viewing the form</span></div><label class='gfield_label gform-field-label' for='input_8_20'>Surveys</label><div class='ginput_container ginput_container_select'><select name='input_20' id='input_8_20' class='large gfield_select' aria-invalid="false" ><option value='True' selected='selected'>True</option></select></div></div><div id="field_8_19" class="gfield gfield--type-select gfield--input-type-select gfield--width-full field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_hidden" data-js-reload="field_8_19" ><div class="admin-hidden-markup"><i class="gform-icon gform-icon--hidden" aria-hidden="true" title="This field is hidden when viewing the form"></i><span>This field is hidden when viewing the form</span></div><label class='gfield_label gform-field-label' for='input_8_19'>Lhasa Newsletter</label><div class='ginput_container ginput_container_select'><select name='input_19' id='input_8_19' class='large gfield_select' aria-invalid="false" ><option value='True' selected='selected'>True</option></select></div></div><div id="field_8_10" class="gfield gfield--type-hidden gfield--input-type-hidden gfield--width-full gform_hidden field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible" data-js-reload="field_8_10" ><div class='ginput_container ginput_container_text'><input name='input_10' id='input_8_10' type='hidden' class='gform_hidden' aria-invalid="false" value='Subscribed to Lhasa marketing newsletter:' /></div></div><div id="field_8_9" class="gfield gfield--type-hidden gfield--input-type-hidden gfield--width-full gform_hidden field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible" data-js-reload="field_8_9" ><div class='ginput_container ginput_container_text'><input name='input_9' id='input_8_9' type='hidden' class='gform_hidden' aria-invalid="false" value='Legitimate Interest' /></div></div><div id="field_8_16" class="gfield gfield--type-hidden gfield--input-type-hidden gfield--width-full gform_hidden field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible" data-js-reload="field_8_16" ><div class='ginput_container ginput_container_text'><input name='input_16' id='input_8_16' type='hidden' class='gform_hidden' aria-invalid="false" value='Web Form' /></div></div><div id="field_8_22" class="gfield gfield--type-date gfield--input-type-date gfield--input-type-datepicker gfield--datepicker-no-icon gfield--width-full gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_hidden" data-js-reload="field_8_22" ><div class="admin-hidden-markup"><i class="gform-icon gform-icon--hidden" aria-hidden="true" title="This field is hidden when viewing the form"></i><span>This field is hidden when viewing the form</span></div><label class='gfield_label gform-field-label' for='input_8_22'>Compliant Date<span class="gfield_required"><span class="gfield_required gfield_required_text">(Required)</span></span></label><div class='ginput_container ginput_container_date'> <input name='input_22' id='input_8_22' type='text' value='//' class='datepicker gform-datepicker dmy datepicker_no_icon gdatepicker-no-icon' placeholder='dd/mm/yyyy' aria-describedby="input_8_22_date_format" aria-invalid="false" aria-required="true"/> <span id='input_8_22_date_format' class='screen-reader-text'>DD slash MM slash YYYY</span> </div> <input type='hidden' id='gforms_calendar_icon_input_8_22' class='gform_hidden' value='https://www.lhasalimited.org/wp-content/plugins/gravityforms/images/datepicker/datepicker.svg'/></div><div id="field_8_23" class="gfield gfield--type-captcha gfield--input-type-captcha gfield--width-full field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible" data-js-reload="field_8_23" ><label class='gfield_label gform-field-label' for='input_8_23'>CAPTCHA</label><div id='input_8_23' class='ginput_container ginput_recaptcha' data-sitekey='6Ldf3jolAAAAAEs47ai9Mz-CccpxB3ke74BDLUNQ' data-theme='light' data-tabindex='0' data-badge=''></div></div><div id="field_8_25" class="gfield gfield--type-honeypot gform_validation_container field_sublabel_below gfield--has-description field_description_below field_validation_below gfield_visibility_visible" data-js-reload="field_8_25" ><label class='gfield_label gform-field-label' for='input_8_25'>Name</label><div class='ginput_container'><input name='input_25' id='input_8_25' type='text' value='' autocomplete='new-password'/></div><div class='gfield_description' 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