Extractables & Leachables (E&L) Testing Services

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. 

At a glance

  • USP <1663>/<1664> and USP <665>/<1665> aligned E&L programs
  • Controlled extractables studies + real-time/accelerated leachables programs
  • Orthogonal screening: LC-MS/MS, GC-MS(/MS), ICP-MS, FTIR
  • Clear deliverables: protocol, chromatograms, tentative IDs, semi-quant/quant data

Extractables vs Leachables (Quick Definitions)

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.

What We Test (Materials & Components)

  • Bioreactors/single-use systems and process-contact materials
  • Polymer systems, elastomers, tubing, stoppers/closures
  • Prefilled syringes and container-closure systems

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) 
 

Get A Quote Fast

To quote quickly, we typically need:

  • Material list/BOM + what’s in contact
  • Product matrix or simulant + route of administration
  • Stage (development vs submission)
  • Lots/timepoints and desired deliverables
  • Timeline

If you’re ready, you can receive a quote here.

Extractables Study Workflow

  1. Controlled extraction using solvents (polar/non‑polar), elevated temperature, and time. 
  2. Orthogonal screening: GC‑MS, LC‑MS, ICP‑MS. 
  3. Tentative identification using spectral libraries and HRAM tools. 
  4. Semi‑quantification relative to surrogate standards. 
  5. Full reporting and toxicological alignment. 

Leachables Study Workflow 

  1. Real‑time and accelerated storage conditions 
  2. Method development and validation for target analytes 
  3. Routine quantification at multiple timepoints 
  4. Toxicological evaluation support 

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

FAQs — Extractables & Leachables Testing

What’s the difference between extractables and leachables?

Extractables are compounds that can be pulled out under exaggerated conditions; leachables are what actually migrate under real product conditions.

Do we need both extractables and leachables studies?

Not always. Scope depends on product type, route of administration, material risk, and stage. We help define a fit-for-purpose program.

Which standards do you align to?

Our programs can align to USP <1663>/<1664>, USP <665>/<1665>, PQRI recommendations, and other applicable guidance.

Can you identify unknown peaks?

We support tentative identification using spectral libraries/HRAM tools and can help confirm targets as needed.

What do you need to quote an E&L program?

Material list/BOM, contact surfaces, product matrix/simulant, route of administration, targets (if any), lot counts/timepoints, and timeline.

What turnaround times should we expect?

Typical controlled extractables studies are ~3–4 weeks; leachables timelines depend on the study design and timepoints.

Ready to test with CA?

Reach out to one of our team members today for a quote or consultation! Typical turnaround varies by method/matrix—ask us for scheduling

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