Assessment of Proposed Cyclohexanone Limits for Containers

A limit of 5 mg was recently proposed as the European Pharmacopoeia limit for residual cyclohexanone in plastic containers for parenteral medical use with a nominal volume greater than 250 ml. Comparison of the proposed limit to published toxicological end-points and current governmental regulations was used to assess the potential risk following exposure. Based on the comparison, no adverse effects would be predicted from clinical exposures to 5 mg residual cyclohexanone in containers with a nominal volume of greater than 250 ml.