Role of Extractables and Leachables in Container Qualification
Extractables and leachables (E&L) play a pivotal role in determining the safety and suitability of pharmaceutical packaging. These studies help identify harmful substances that may migrate from the container closure system into the drug product during storage and use. Regulatory authorities such as the USFDA, EMA, and WHO mandate comprehensive E&L assessments to ensure packaging…
Read More “Role of Extractables and Leachables in Container Qualification” »