{"id":1658,"date":"2026-10-06T12:30:56","date_gmt":"2026-10-06T12:30:56","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/q3d\/"},"modified":"2026-10-06T12:30:56","modified_gmt":"2026-10-06T12:30:56","slug":"q3d","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/q3d\/","title":{"rendered":"Q3D \u2013 Guideline for Elemental Impurities"},"content":{"rendered":"<p>ICH Q3D(R2) Guideline for Elemental Impurities is a quality guideline for the control of elemental impurities in new drug products (medicinal products), and it establishes Permitted Daily Exposures (PDEs) for 24 Elemental Impurities (EIs) for drug products administered by the oral, parenteral and inhalation routes of administration. In addition, guidance is provided in Q3D(R2) on how to develop an acceptable level for EIs for drug products administered by other routes of administration.<\/p>\n<p>The current Q3D(R2) Guideline reached <em>Step 4<\/em> in April 2022, and included a correction of PDEs for Gold, Silver and Nickel; Gold and Silver monographs; and an addition of limits for elemental impurities by the cutaneous and transcutaneous route. The Q3D(R2) Guideline replaces the previous Q3D(R1) Guideline, which reached <em>Step 4<\/em> of the ICH process in 2019, further to the initial Q3D Guideline which reached <em>Step 4<\/em> in 2014.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ICH Q3D(R2) Guideline for Elemental Impurities is a quality guideline for the control of elemental impurities in new drug products (medicinal products), and it establishes Permitted Daily Exposures (PDEs) for 24\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[18],"guideline_tag":[],"rd_phase":[],"class_list":["post-1658","guideline","type-guideline","status-publish","hentry","guideline_category-quality"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1658","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/guideline"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1658\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1658"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1658"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1658"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1658"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}