ebook: Extractables and leachables: a guide to analytical methods

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.