Extractables and Leachables (E&L) analyses require in-depth studies of packaging contaminants both extracted under extreme conditions, such as high temperatures and pressures and organic solvents, and those that leach from the container closures under standard storage conditions respectively. E&L ranging from volatile to non-volatile and elemental impurities have the potential to interact with drug products, even in trace amounts. Thus, these toxic contaminants must be tested thoroughly even in complex matrices. To ensure safety and regulatory compliance, you need sensitive analytical systems that deliver accurate and reproducible results.
See how Jordi Labs addresses challenges of identification and quantification of diverse trace unknowns in E&L analysis with Agilent’s high resolution accurate mass instruments, and learn how they are able to achieve ppb level detections of trace level elemental impurities in undiluted high salt matrices.
Learn a multidetector approach for quantitation using the combined strengths of triple LC/MS with UV and CAD as well as GC/MS with simultaneous FID.
A major concern regarding the accuracy of E&L studies is quantitative error due to response factor (RF) variation. Surrogate standards are frequently applied in E&L analysis. Recent publications have highlighted the risks posed by RF variation for both LC/MS and GC/MS. We present methods for quantitation with more consistent RFs which mitigate the need for large UFs.
Learn:
Two case studies looking at challenges in the profiling of extractables.
The first part of this webinar looks at the analytical challenges associated with Polysorbate 80 as a solvent, and provides strategies to help address some of these challenges. The second part of this webinar presents an extractables study and a subsequent simulation study conducted on multilayer IV bags used for packaging sterile water for injection (SWFI) and glycine buffer solution.
Learn:
Find links to products, videos and other resources to help you develop methods and address regulatory requirements.
Find links to products, videos and other resources to help you confidently meet regulatory requirements for the detection and quantification of nitrosamine impurities.
Agilent can help your lab implement effective elemental impurities testing by providing an integrated approach to keeping your lab compliant. Find links to products, app notes and more.
Agilent provides the accuracy and reproducibility you require. Find links to products, videos and other resources.
DE.160625