Typical extractables and leachables (E/L) studies aim to identify, quantify and ultimately minimise any impurities that can migrate from packaging into a final product or drug.
Gas or liquid chromatography-mass spectrometry (LC/MS) or (GC/MS) have been widely used in extractables studies however, there are several challenges associated with E&L analyses including:
- Detection and quantification of unknowns
- Sensitivity and detection at trace levels
- Reducing uncertainty factors
- Increasing sample throughput while reducing manual errors and sources of contamination
This ebook examines how these challenges can be overcome with advanced analytical techniques.
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