Extractables & Leachables (E&L)
Extractables and leachables assessments help identify compounds that may arise from packaging, delivery systems, product contact materials, and related components.
Teleios supports scientifically designed E&L studies based on the material, product, route of administration, and intended use.
What We Can Support
- Extractables studies
- Leachables investigations
- Material screening
- Targeted and non targeted analysis
- Volatile and semi volatile analysis
- Elemental analysis when appropriate
- Method development for identified compounds
- Packaging and delivery system investigations
Typical Analytical Questions
- What compounds can be extracted from the material?
- Which compounds may migrate into the drug product?
- Are observed compounds associated with packaging or another source?
- What analytical methods are appropriate for monitoring identified leachables?
Analytical Approach
Study design considers material composition, contact conditions, route of administration, and intended use. Non targeted screening by LC-QTOF/MS and GC-MS is paired with elemental analysis and targeted follow up where appropriate.
Regulatory & Compendial Framework
Depending on the program, material, and intended use, studies may consider:
- USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging and Delivery Systems
- USP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging and Delivery Systems
- Applicable USP packaging chapters
- Relevant FDA guidance and product specific expectations
Not every listed framework applies to every study. Applicable expectations depend on product type, development stage, route of administration, material, intended use, and jurisdiction.