This ebook takes an in-depth look at advanced analytical methods for extractables and leachables analysis in the pharma industry.
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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