The Importance Of Characterizing The Extractable And Leachable Profile Of Stoppers For Drug Stability

By Todd Jasinski

Extractables and leachables (E&L) testing is an essential process in the pharmaceutical industry to ensure the safety and quality of drug products. It involves examining the potential migration of substances from containers, packaging materials, and drug delivery systems into the drugs themselves.

The significance of E&L testing lies in its ability to identify potential risks associated with containers and packaging materials. By identifying extractables and leachables, manufacturers can make informed decisions regarding product safety. This testing also helps evaluate potential drug interaction with degradants and reactants that could harm patients or cause drug instability.

Common industry approaches to E&L testing involve using chromatography and mass spectrometry to detect and identify a broad range of compounds. West Pharmaceutical Services, Inc. has implemented orthogonal techniques using liquid and gas chromatography to identify volatile, semi-volatile, and non-volatile compounds. This comprehensive approach allows for a more thorough characterization of the leachable profile.

As the pharmaceutical industry continues to innovate, E&L testing will remain crucial for maintaining safety, regulatory compliance, and customer satisfaction. West Pharmaceutical Services, Inc. is committed to utilizing their experience and expertise to support customers in the field of leachables testing.