TABLE V

Sample Assessment: Highest Concentrations Detected and Estimated Total Daily Doses

Leachablea
Highest Concentration Detectedx ppm
Estimated Total Daily Exposure Following Topical Ocular Administration (Both Eyes Combined)≤ y.yy μg/dayb,c
  • aRecord name of leachable or relative retention time if unidentified.

  • bGiven the administration instructions available for the product (i.e., instill 2 drops to both eyes daily; use actual drop size).

  • cppm = mg/L; leachable conc. (mg/L; μg/1000 μL) × drop size (μL/drop) × number drops/eye/day × 2 eyes = y.yy μg/day.