{"id":794,"date":"2023-03-27T08:37:35","date_gmt":"2023-03-27T08:37:35","guid":{"rendered":"https:\/\/mahalakshmilaboratories.com\/?page_id=794"},"modified":"2023-06-28T10:40:43","modified_gmt":"2023-06-28T10:40:43","slug":"impurity-synthesis","status":"publish","type":"page","link":"https:\/\/mahalakshmilaboratories.com\/index.php\/impurity-synthesis\/","title":{"rendered":"Impurity Synthesis"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"794\" class=\"elementor elementor-794\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-487c5685 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"487c5685\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&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-6e407039\" data-id=\"6e407039\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-50fbed32 elementor-widget elementor-widget-heading\" data-id=\"50fbed32\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.11.5 - 14-03-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h2 class=\"elementor-heading-title elementor-size-default\">Impurity Synthesis<\/h2>\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-482208e3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"482208e3\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&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-4cd84fa1\" data-id=\"4cd84fa1\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1b16f114 elementor-widget elementor-widget-heading\" data-id=\"1b16f114\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Impurity Synthesis<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-539140e4 ser_inner_p elementor-widget elementor-widget-text-editor\" data-id=\"539140e4\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.11.5 - 14-03-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#818a91;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#818a91;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p class=\"abt_p pt-15\">An impurity in a drug product, that remain with the active pharmaceutical ingredients (API), or develop during formulation, or upon aging of both API and the drug product, is any component of the drug product that is not the chemical entity defined as the drug substance or an excipient in the drug product. The existence of these impurities even in trace amounts may influence the efficacy and safety of the drug product. Therefore, identification and characterization of impurities called Impurity Profiling is now becoming significant critical product quality parameter and getting critical review from regulatory authorities.<\/p>\n<p class=\"abt_p pt-15\">International Conference on Harmonization (ICH) has published guidelines for validation methods for analysis of impurities in new drug products, new drug substances, residual solvents &amp; microbiological impurities for registration of pharmaceuticals. Most active pharmaceutical ingredients (API) are produced by organic chemical synthesis. Various components, including residual solvents, trace amounts of inorganic, and organic components can be generated during such a process. Those components remaining in the final API are considered as impurities.<\/p>\n<p class=\"abt_p pt-15\">We develop and manufacture and qualify impurities with charecterisation data suiting to our requirement and also offers a wide range of high purity Impurity Standards for the pharmaceutical industries on milligram to gram scale at competitive price. We have a technical capability to synthesize, isolate and purify the Impurity Standards to their purest form. We also offer custom synthesis of impurity compounds as on requests.<\/p>\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Impurity Synthesis Impurity Synthesis An impurity in a drug product, that remain with the active pharmaceutical ingredients (API), or develop during formulation, or upon aging of both API and the drug product, is any component of the drug product that is not the chemical entity defined as the drug substance or an excipient in the&hellip; <a class=\"more-link\" href=\"https:\/\/mahalakshmilaboratories.com\/index.php\/impurity-synthesis\/\">Continue reading <span class=\"screen-reader-text\">Impurity Synthesis<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":[],"_links":{"self":[{"href":"https:\/\/mahalakshmilaboratories.com\/index.php\/wp-json\/wp\/v2\/pages\/794"}],"collection":[{"href":"https:\/\/mahalakshmilaboratories.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mahalakshmilaboratories.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mahalakshmilaboratories.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mahalakshmilaboratories.com\/index.php\/wp-json\/wp\/v2\/comments?post=794"}],"version-history":[{"count":7,"href":"https:\/\/mahalakshmilaboratories.com\/index.php\/wp-json\/wp\/v2\/pages\/794\/revisions"}],"predecessor-version":[{"id":1161,"href":"https:\/\/mahalakshmilaboratories.com\/index.php\/wp-json\/wp\/v2\/pages\/794\/revisions\/1161"}],"wp:attachment":[{"href":"https:\/\/mahalakshmilaboratories.com\/index.php\/wp-json\/wp\/v2\/media?parent=794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}