Extractables & Leachables (E&L) Studies
Comprehensive evaluation of potential contaminants migrating from packaging materials and manufacturing systems to ensure product safety, quality, and regulatory compliance.
Study Capabilities
- Extractables studies under controlled conditions
- Leachables monitoring in real-time & accelerated studies
- Worst-case simulation (pH, temperature, solvents)
- Identification & quantification of organic/inorganic compounds
Applications
- Container Closure Systems (CCS)
- Pharmaceutical packaging materials
- Medical devices & delivery systems
- Single-use bioprocess systems
Analytical Techniques
GC-MS, LC-MS/MS, ICP-OES, ICP-MS, FTIR, and UV-Visible spectroscopy for accurate detection and characterization.
Regulatory Compliance
Studies aligned with USP <1663>, USP <1664>, ICH guidelines, and FDA expectations with full documentation support.
Key Benefits
Ensures product safety, supports regulatory submissions, and minimizes contamination risks across the product lifecycle.