RT Journal Article
SR Electronic
T1 Moving Forward towards Standardized Analytical Methods for Extractables and Leachables Profiling Studies
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 471
OP 476
DO 10.5731/pdajpst.2015.01089
VO 69
IS 4
A1 Dennis Jenke
YR 2015
UL http://journal.pda.org/content/69/4/471.abstract
AB This commentary considers the standardization of analytical methods used in extractables and leachables screening and proposes that method standardization is not the end goal but rather the necessary first step for enabling efficient, effective, robust, and consistent extractables and leachables profiling. Standardized methods are the platform upon which a knowledge set and a knowledge management process can be built, and it is the combination of the methods, the set, and the process that facilitates extractables and leachables profiling.