INTRODUCTION TO EXRACTABLES AND LEACHABLES

摘要

Extractables and leachables (E&L) are constituents of all primary packaging components that have the potential to accumulate in pharmaceutical and medical device products over time. Both drug product and the container closure have formulations which upon contact, will inevitably give rise to chemical interaction, leaching and sorption. This can lead to contamination, compromise of the packaging protection characteristics, loss of drug potency or adulteration of the products. Ideally, gaining an understanding of a material's composition as well as its physicochemical properties will aid the selection and qualification of appropriate materials early on in the development process to ensure safety, efficacy, compatibility and compliance to maintain the integrity of a drug product throughout it's intended shelf life, as well its delivery. Extractables and leachables testing of all components that come into contact with the drug product formulation are an essential part of any regulatory application. Such investigations must be conducted in accordance with recommended guidance in a current Good Manufacturing Practices (cGMP) compliant laboratory to enable regulatory submissions.