White Paper: Top 7 Considerations When Conducting Extractables & Leachable Studies
Published February 2021
Abstract:
Extractable and leachable studies are performed to stimulate intended use and worst-case scenario conditions to reveal potential contaminants in a drug formulation. Topics covered in this white paper are:
- Extractables & Leachables Definition
- Importance of Extractables & Leachables Analysis
- Principles of Extractables & Leachables Study Design
- Extractables & Leachables Regulations & Guidelines
- Analytical Evaluation of Extractables & Leachables
- Assessment of Extractables Data
- Extractables & Leachables at Dalton
Keywords: extractables, leachables, contaminants, stability, compliance, recalls, FDDA, EMA, Health Canada, IICH, pharmacopeia, impurity, quality, container closure system, manufacturing, GMP
Click here to view White paper: Top 7 Considerations When Conducting Extractables & Leachable Studies