White Paper: Extractables & Leachables in The Pharma Industry
Published April 2023
Abstract:
This whitepaper provides an overview of Extractables and Leachable (E&Ls) in the pharmaceutical industry. Extractables are chemical compounds that can be extracted from the product enclosure system using various stress conditions in the laboratory. At the same time, Leachables are chemicals that leach from the product enclosure system into the drug product under conditions that are representative of the drug lifecycle. The assessment of any detected extractables and Leachables that are above the analytical evaluation threshold is critical to determining the overall product safety.
This white paper covers:
- Regulatory Considerations of Extractables and Leachables
- Importance of Extractable and Leachable Testing
- Safety Concern Threshold (SCT)/ Analytical Evaluation Threshold (AET)
- Analytical Techniques
- Extractable and Leachable study
- Material Characterization
- Simulation Study/ Method Validation
Keywords: impurity, extractables, Leachables, API, API manufacturing, ICH, critical material attribute, FDA, EMA, Health Canada, pharmacopeia, ISO, packaging
Click here to view the white paper: Extractables & Leachables in The Pharma Industry