In line with the Ph. Eur. implementation strategy for the ICH Q3D guideline for elemental impurities, the test for heavy metals (2.4.8) has been deleted.
However, to retain the aspect of control for elemental impurities, the ‘Purified water in bulk’ section of the monograph has been revised to address the situation where purified water inbulk does not comply with the requirements for conductivity prescribed in Water for injections (0169) in bulk.
This is the new section on elemental impurities:
“Elemental impurities: If purified water in bulk does not meet the requirement for conductivity prescribed for Water for injections (0169) in bulk, a risk assessment according to general chapter 5.20 Elemental impurities is carried out. The risk assessment should consider the role of water in the manufacturing process, in particular when water is used in a process but is no longer present in the final product.”