Assessment of Extractables and Leachables Associated with Pharmaceutical Packaging

Introduction

Extractables and leachables studies are critical for maintaining the quality of your drug product and complying with GMP regulations during drug development and final batch release. Exposure to extractables and leachables could have a detrimental impact on the safety and efficacy of a final drug product. Testing for these contaminants is critical in every part of pharmaceutical packaging including the packaging system used to store drug products.