PT  - JOURNAL ARTICLE
AU  - Jenke, Dennis
TI  - Accurate or Protective: What Is the Goal of Non-Targeted Extractables and Leachables Quantitation and Identification?
AID  - 10.5731/pdajpst.2023.012868
DP  - 2024 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 358--366
VI  - 78
IP  - 3
4099  - http://journal.pda.org/content/78/3/358.short
4100  - http://journal.pda.org/content/78/3/358.full
SO  - PDA J Pharm Sci Technol2024 May 01; 78
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.