RT Journal Article
SR Electronic
T1 Accurate or Protective: What Is the Goal of Non-Targeted Extractables and Leachables Quantitation and Identification?
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 358
OP 366
DO 10.5731/pdajpst.2023.012868
VO 78
IS 3
A1 Jenke, Dennis
YR 2024
UL http://journal.pda.org/content/78/3/358.abstract
AB Leachables are quantified and identified to enable their quantitative toxicological safety risk assessment (qTSRA). The leachable’s reported concentration and identity must meet certain quality expectations to be suitable for qTSRA. In this Correspondence, the author considers accuracy and protectiveness as competing key quality attributes and suggests that protectiveness is the proper quality attribute for qTSRA, as qTSRA is based on the foundation that a leachable’s potential adverse effect on patient health and safety must not be underestimated. Considering this conclusion, means of making concentration estimates and proposed identities protective are discussed.