title: Moving Forward towards Standardized Analytical Methods for Extractables and Leachables Profiling Studies.
abstract: 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.
authors.affiliation: Baxter Healthcare Corporation, 25212 West Illinois Route 120, Round Lake, IL 60073 USA dennis_jenke@baxter.com.
authors.forename: Dennis
authors.initials: D
authors.lastname: Jenke
mesh_terms: D004059:Diffusion of Innovation; D004340:Drug Contamination; D016503:Drug Delivery Systems; D004349:Drug Packaging; D005544:Forecasting; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011786:Quality Control; D012015:Reference Standards; D012997:Solvents / Q000737:chemistry; D013678:Technology, Pharmaceutical / Q000592:standards* / Q000639:trends
chemical_list: D004364:Pharmaceutical Preparations; D012997:Solvents