Pharmaguideline Forum
Why control threshold limit is specifically defined as 30% of PDE in ICH Q3D guideline (Elemental impurities)?
Regulatory
Mithun
(Mithun)
August 26, 2021, 11:18am
1
https://database.ich.org/sites/default/files/Q3D-R1EWG_Document_Step4_Guideline_2019_0322.pdf