Analytical approaches for the evaluation of data deficient simulated leachable compounds in ENDS products: a case study.

ABSTRACT: Leachable investigations are routinely undertaken across a range of sectors (e.g., pharmaceuticals, medical devices, etc.) to determine whether chemicals from a container closure system transfer into a product under normal conditions of use. For Electronic Nicotine Delivery Systems (ENDS) the container closure system includes all materials in contact with the e-liquid that is aerosolized and subsequently inhaled by the user. Currently, there is no guidance for conducting leachable studies for ENDS products, however, there are relevant guidance documents for orally inhaled drug products that can be applied to an ENDS container closure system. We present a case study of the analytical investigation of two leachable compounds identified in simulated leachable studies using aged JUULpods fille

SUBMITTER: Smith C 

PROVIDER: S-EPMC10436322 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature