Table 2. ICH Guidelines for Inhalation Permitted Daily Exposures (PDE) for Elemental Impurities along with Their Respective Analysis Group and Select Figures of Merita.

Analysis group 1: all quality control measures assessed (gray highlight); group 2: less-rigorous quality control (no highlight); group 3: elements were monitored but not quantitated (no highlight). MDL are based on ∼3.5σ of concentration of 90 method blanks.