Extractables and Leachables (E&L) Testing

Introduction: Why ICP-MS Is Essential in E&L Investigations Whenever a drug product comes into contact with a container-closure system, manufacturing […]

Introduction: Why Leachables Monitoring Must Be Central to Your Stability Program Many sponsors still approach stability studies primarily as a

Introduction: Plastic packaging materials are widely used in pharmaceutical products because they are lightweight, durable, and cost-effective. However, these materials

Introduction: Why Technique Selection Is the Foundation of Every E&L Study In GC-MS vs LC-MS in Extractables and Leachables Testing,

Introduction: Why AET Derivation Is the Defining Step in E&L Studies The Analytical Evaluation Threshold (AET) is the single most

Introduction: The Most Overlooked Challenge in E&L Science Unknown Peak Identification in Extractables and Leachables (E&L) testing is among the

Introduction: Extractables and Leachables from Elastomeric Closures are a major focus area in pharmaceutical packaging and regulatory compliance because elastomeric

Introduction: Why Solvent Selection in Extractables Studies Is a Regulatory Science Decision One of the most overlooked variables in extractables

Primary Regulatory and Technical Challenges in Combination Device Development Chemical migration assessment for drug-device combination systems plays a central role

Introduction: Toxicological Assessment in Extractables & Leachables Studies is a critical scientific process used to evaluate whether chemical compounds migrating