![Sample our Physical Sciences journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/110819/TOC-Subject-Sample-2021-Physical-Sciences.jpg"})
Abstract
The term “leachables” refers to impurities in pharmaceutical products whose origin is the pharmaceutical container closure system in either direct or indirect contact with the formulation. Potential leachables identified through laboratory studies of pharmaceutical container closure system components are referred to as “extractables.” Extractables and leachables are most often chemical additives to plastic and elastomeric container closure system components, or organic residues on metal and glass surfaces. HPLC and LC/MS are used for the detection, identification and quantitation of extractables and leachables. This review presents and discusses the extractables/leachables issue within the contexts of both regulatory and analytical sciences. It also thoroughly reviews and describes the recent applications of both HPLC and LC/MS to this challenging and intriguing issue in pharmaceutical development.
Keywords:
ACKNOWLEDGMENTS
The authors wish to acknowledge their respective organizations as well as the Product Quality Research Institute for their support. Also acknowledged are Mr. James Mullis of Boehringer Ingelheim Pharmaceuticals, Dr. Thomas, N. Feinberg and Dr. Alan Hendriker from Catalent Pharma Solutions (Dr. Hendriker is currently with OpAns).