ABSTRACT

INTRODUCTION: ORIGIN AND IMPORTANCE OF EXTRACTABLES AND LEACHABLES In this chapter the important elements of extractables and leachables, with which those in the pharmaceutical industry should be familiar, are discussed. On completion of this chapter, the reader should be able to

l Understand the extractables/leachables expectations in guidelines, guidances, United States Pharmacopoeia (USP), International Conference on Harmonization (ICH), U.S. Code of Federal Regulations (CFR), and other regulatory documents

What is expected or required? l Identify sources of extractables from packaging and process materials such as plastic,

glass, and rubber Where do E&L (extractables and leachables) originate?