Analytical Leachables Studies

This chapter focuses on the crucial aspects of analytical leachables studies in the pharmaceutical industry, emphasizing the identification and quantification of leachables that may migrate from container closure systems into drug products. The objective is to outline a robust strategy for leachables testing, including the selection of appropriate analytical methods and addressing challenges unique to leachables testing. The methodology involves performing controlled extraction studies on materials associated with pharmaceutical products to identify potential leachables. The chapter discusses the correlation between extractables and leachables, highlighting their importance in control strategies. Results indicate that while leachables are generally a subset of extractables, various exceptions exist, complicating their analysis due to interference from active ingredients and impurities. Regulatory expectations and historical data from actual drug products illustrate the key attributes needed for a successful leachables program. The chapter concludes with recommendations for testing and managing leachables to ensure drug safety.