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.
Download Now
ebook: Extractables and Leachables: a guide to analytical methods
Topics
- Analytical and bioanalysis
- Bioprocessing and biomanufacturing
- Chromatography and separations
- Formulation and drug delivery
- Impurities, contaminants and nitrosamines
- Packaging, containers and labelling
- Quality, microbiology and contamination control
- Regulation and compliance
- Spectroscopy and imaging
- Thermo Fisher Scientific
