• Regulatory NewsRegulatory News

    ICH Reverts to Previous Version of Guideline on Residual Solvents

    The International Council for Harmonisation (ICH) has further explained why it decided to go back and change the Permissible Daily Exposure (PDE) for ethylene glycol (EG), and then more recently, to reverse that decision and revert back to the original figure. Prior to 2017, the ICH Q3C guideline, which deals with residual solvents, included a Summary Table 2 that listed EG as a Class 2 residual solvent with a PDE of 6.2 mg/day. But in 2017, ICH was notified by an exter...