{"id":6257,"date":"2021-02-24T17:02:39","date_gmt":"2021-02-24T17:02:39","guid":{"rendered":"http:\/\/164.90.225.225\/2023\/05\/02\/nitrosamine-free-development-process\/"},"modified":"2023-05-25T11:04:47","modified_gmt":"2023-05-25T10:04:47","slug":"nitrosamine-free-development-process","status":"publish","type":"post","link":"https:\/\/www.quinta.cz\/cs\/2021\/02\/24\/nitrosamine-free-development-process\/","title":{"rendered":"Nitrosamine free development process"},"content":{"rendered":"<p>A thorough evaluation of each step of the #drugdevelopment process is the only way to be certain you\u2019re free from nitrosamine contamination.<\/p>\n<p>In its original advice to MAH\u2019s, the European Medicines Agency warned manufacturers that it had identified 5 main root causes of formation and contamination. The risk from the raw materials, formation during the processing of the APIs, the use of certain solvents, reagents or catalysts, &amp; indeed the use of recycled materials were featured as real risks.<\/p>\n<p>By evaluating and then testing each individual material &amp; step taken in the manufacturing process, you can correctly understand the influence of factors such as temperature change and solvent type used; each of which can have an impact and increase the amount of, or in some cases even cause, nitrosamines. &nbsp;Only then you can be certain that the end product is safe and contamination free. <\/p>\n<p>With the saga continuing to impact the pharma world, there has never been a more critical time to choose the correct partner.<\/p>\n<p>Chartwell Actives LLC and QUINTA-ANALYTICA work together to offer a holistic approach to evaluating, performing risk-assessments, and running experimental testing for nitrosamines.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Thanks to the partnership of Chartwell Actives LLC and QUINTA-ANALYTICA we help ensure that your development process is nitrosamine free.<\/p>\n","protected":false},"author":6,"featured_media":6258,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-6257","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorised"],"_links":{"self":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/6257","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/comments?post=6257"}],"version-history":[{"count":1,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/6257\/revisions"}],"predecessor-version":[{"id":6711,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/6257\/revisions\/6711"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/media\/6258"}],"wp:attachment":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/media?parent=6257"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/categories?post=6257"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/tags?post=6257"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}