Extractables & Leachables (E&L) Capabilities 

CA Analytical Testing Services provides comprehensive Extractables & Leachables (E&L) testing for pharmaceuticals, medical devices, combination products, bioprocessing systems, and packaging materials. Our laboratory delivers regulatory‑aligned, science‑based testing with complete documentation for FDA, USP <1663>/<1664>, USP <665>/<1665> , and PQRI expectations. 

Core E&L Capabilities 

– Complete Extractables studies (controlled extraction) 
– Comprehensive Leachables studies under real-time and accelerated conditions 
– Material compatibility and risk‑based assessments 
– Orthogonal analytical screening to maximize coverage 
– Specialized workflows for polymeric materials, elastomers, tubing, closures, bioreactors, and prefilled syringes 

Analytical Techniques 

• LC‑MS/MS (Small molecules, semi-volatiles, non-volatiles) 
• GC‑MS and GC‑MS/MS (Volatiles and semi-volatiles) 
• ICP‑MS (Metals, catalyst residues, elemental impurities) 
• Headspace GC‑MS (Residual solvents) 
• FTIR (Polymer identification) 
• UV‑Vis, CAD, pH (Supporting tests) 
 

Regulatory Alignment 

• Our E&L programs are aligned with: 
• USP <1663> Extractables 
• USP <1664> Leachables 
• USP <665>/<1665> Plastic components and systems 
• PQRI OINDP, Parenteral, and PODP recommendations 
• ISO 10993, FDA, ICH Q3E, and industry best practices 

Industries Supported 

– Pharmaceutical manufacturers 
– Medical device companies 
– Biologics and cell/gene therapy groups 
– Packaging and component manufacturers 
– CDMOs and CMOs 

Turnaround Times 

• Typical controlled extractables study: 3–4 weeks 
• Leachables programs follow customer study design 

Deliverables 

• Full E&L study protocol 
• Detailed analytical results and chromatograms 
• Tentative IDs with library match scores 
• Semi‑quantitative and quantitative data 
• Toxicological risk assessment support

Extractables are chemical compounds that can be pulled out of a material—such as plastics, elastomers, tubing, or container–closure systems—when exposed to aggressive solvents, elevated temperatures, or exaggerated laboratory conditions. Extractables studies identify the full chemical profile of what could migrate from a material under worst-case scenarios.

Leachables are chemical compounds that actually migrate from packaging, processing equipment, or device components into the real drug product or clinical solution under normal storage, use, and shelf-life conditions. Leachables studies focus on what does migrate, using targeted, validated methods to ensure patient safety and regulatory compliance.