Table II

Comparison of the Extractables and Accelerated Leachables Results of a Prefilled Syringe System

ExtractablesAccelerated Leachables
GoalExtractables profileLeachables profile
Solution mediaWater and 40% organic water at different pHsDrug products
Time @ Temperature4 days @ 70 °C90 days @ 37 °C
Results

  • Irgacure 184

  • Benzoic acid

  • Cyclohexanone

  • Benzaldehyde

  • Isoborneol

  • Isobornyl acrylate

  • Poly tetrahydrofuran

Same profile observed, but at much lower concentrations