ICH Q3D Elemental Impurity Guidelines: Are You Prepared for January 2018?

• By: Staff Editor
• Date: September 07, 2017

ICH Q3D Elemental Impurity Guidelines: Are You Prepared for January 2018?

While both ICH Q3D and USP General Chapters <232> and <233> are scheduled to go into effect in 2018, implementation requires extensive prior work. The new elemental impurities limits require more sophisticated analytical technology, such as ICP-MS, not routinely used in QC labs. The ultra-sensitive analytical method must be validated specifically for all of your different dosage forms.