Choosing the right ICH Q3E Extractables & Leachables (E&L) Testing Laboratory is one of the most important decisions a sponsor makes during product development. The quality of your chosen CRO directly affects compliance, long-term product safety, and the strength of your regulatory submissions. A dependable partner helps you avoid late-stage risks, improves data accuracy, and ensures your documentation aligns with ICH Q3E and ISO 10993-18 expectations. With the right laboratory, sponsors gain reliable results, reduced delays, and a smooth path to regulatory approval.
🔍 Summary: What You Will Learn in This Article
- Key factors to evaluate when choosing an ICH Q3E E&L Testing Laboratory
- A complete step-by-step sponsor checklist for CRO qualification
- How to verify analytical expertise, instrumentation, and regulatory readiness
- The importance of controlled extractables studies and AET determination
- Common E&L testing mistakes and how to avoid them
- How ResolveMass Laboratories Inc. supports full ICH Q3E compliance and transparent reporting
1. Why Selecting the Right ICH Q3E Extractables & Leachables (E&L) Testing Laboratory Matters
Selecting a qualified ICH Q3E Extractables & Leachables (E&L) Testing Laboratory is essential for regulatory success, product safety, and long-term risk management. An inexperienced or under-equipped CRO can miss key impurities, create data gaps, or generate delays that impact FDA, EMA, or Health Canada submissions. Regulatory agencies expect clear, traceable, and defensible E&L data for all materials that come into contact with drug products.
ResolveMass Laboratories Inc. delivers end-to-end E&L testing services for pharmaceuticals, medical devices, and combination products. Their structured approach ensures that every study aligns with the newest ICH Q3E and USP <1663>/<1664> requirements, giving sponsors confidence in both the analytical process and the final regulatory submissions.
2. Sponsor’s Checklist for Selecting an ICH Q3E E&L Testing Laboratory
A structured checklist helps sponsors evaluate CROs and confirm they meet scientific, technical, and regulatory expectations. Each of the following factors is essential for producing accurate, defensible results that support global submissions. A CRO aligned with your product type and regulatory goals will deliver stronger data and minimize project risks.
| Evaluation Factor | Why It Matters | What to Look For |
|---|---|---|
| Regulatory Compliance | Ensures global submission readiness | ICH Q3E, USP <1663>, <1664>, ISO 10993-18 |
| Analytical Capabilities | Determines accuracy and detection range | GC-MS, LC-MS/MS, ICP-MS, TOF-MS |
| Material Expertise | Critical for complex matrices | Polymers, coatings, elastomers, adhesives |
| Study Design Support | Ensures tailored E&L study plans | Custom E&L Study Design Services |
| Turnaround Time | Affects development speed | Fast E&L Testing Services |
| Regulatory Documentation | Essential for submissions | E&L Testing for Regulatory Submission |
Each factor plays a direct role in ensuring smooth progress through ICH Q3E Extractables & Leachables (E&L) Testing Laboratory qualification. A trusted CRO will address both scientific requirements and regulatory expectations without compromise.
3. Analytical Techniques: The Core of High-Quality E&L Testing
A dependable ICH Q3E Extractables & Leachables (E&L) Testing Laboratory must offer a complete suite of analytical techniques that can detect, identify, and quantify trace-level impurities. These tools determine how thoroughly extractables and leachables are profiled, especially in sensitive formulations or high-risk delivery systems. Strong analytical capability ensures every compound of interest is captured, reported, and properly evaluated for regulatory submissions.
Key Analytical Techniques Include:
- Gas Chromatography–Mass Spectrometry (GC-MS)
- Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS)
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
- Thermal Desorption GC-MS (TD-GC-MS)
- UV-Vis Spectroscopy and FTIR Analysis
Learn more here: Analytical Techniques for E&L Testing
4. Experience and Expertise in Multi-Matrix Systems
A reliable ICH Q3E Extractables & Leachables (E&L) Testing Laboratory must understand the behavior of multiple material types, including elastomers, polymers, coatings, and full container-closure systems. Multi-matrix expertise helps ensure that no extractable is missed, even in complex product designs where each material may interact differently.
ResolveMass Laboratories offers specialized Multi-Matrix E&L Testing Services and dedicated E&L Testing for Medical Devices, helping sponsors understand every impurity across all product components. This approach reduces blind spots and improves the accuracy of risk assessments.
5. Compliance with ICH Q3E, USP, and ISO Standards
Regulatory alignment is essential for high-quality E&L testing. A credible CRO follows global standards that define how impurities are characterized, evaluated, and reported. Compliance with these frameworks ensures your data withstands regulatory scrutiny and prevents costly repeat studies.
Key Standards Include:
- ICH Q3E for impurities in pharmaceutical products
- USP <1663>/<1664> for extractables and leachables guidance
- ISO 10993-18 for chemical characterization in medical devices
Learn more here:
ICH Q3E Extractables & Leachables Testing Services
USP Extractables & Leachables Guidance
6. Risk Assessment and Analytical Evaluation Threshold (AET)
A risk-based strategy is central to meeting ICH Q3E expectations. The Analytical Evaluation Threshold (AET) defines the lowest concentration at which a compound must undergo toxicological evaluation. Proper AET calculation allows laboratories to focus on relevant impurities, avoid unnecessary investigations, and maintain patient safety.
ResolveMass supports sponsors with AET Determination and Risk Assessment Studies, ensuring all necessary impurities are identified and evaluated according to ICH Q3E standards.
7. Controlled Extractables Study Design
A controlled extractables study serves as the foundation of every E&L program. These studies simulate worst-case extraction conditions to reveal the full impurity profile of product-contact materials. Proper study design ensures repeatability, scientific clarity, and regulatory acceptance.
Learn more about the Controlled Extractables Study Process, built to maintain precision and defensible methodology.
8. Speed, Cost, and Data Integrity
In today’s fast-moving development environment, sponsors need an ICH Q3E Extractables & Leachables (E&L) Testing Laboratory that can deliver accurate results without slowing down project timelines. Fast turnaround is essential, but it must never compromise data quality or regulatory defensibility. ResolveMass Laboratories supports programs with efficient timelines through Fast E&L Testing Services, while also offering clear, predictable pricing through their Affordable E&L Testing Solutions.
Their audit-ready documentation ensures complete traceability, transparent data interpretation, and smooth integration into global submission packages. This balance of speed, quality, and integrity reduces project risks and strengthens overall confidence.
9. Data Reporting and Regulatory Submission Support
A strong E&L testing partner must deliver clean, well-structured reports that can be directly included in submissions to the FDA, EMA, and Health Canada. These reports should clearly explain each analytical decision, identify all detected impurities, and show how the study aligns with ICH Q3E and USP expectations.
ResolveMass Laboratories provides detailed data packages designed to support efficient regulatory review. Their transparent reporting reduces follow-up questions, shortens review timelines, and helps sponsors present a complete impurity profile with confidence.
Learn more here: Regulatory Submissions for E&L testing support.
10. Partnering with ResolveMass Laboratories Inc.
With deep experience in ICH Q3E Extractables & Leachables (E&L) Testing, ResolveMass Laboratories offers deep scientific expertise and validated analytical platforms. Their approach combines strong technical capabilities with clear communication and development-friendly timelines. From early design phases to final submission, ResolveMass ensures that every impurity is identified, evaluated, and documented in line with global regulatory standards.
Learn more about their specialized services:
Conclusion: Making the Right Choice for ICH Q3E Compliance
Selecting the right ICH Q3E Extractables & Leachables (E&L) Testing Laboratory requires a balance of scientific expertise, reliable technology, regulatory compliance, and clear reporting practices. A strong CRO partner not only safeguards product quality but also accelerates submission timelines and ensures every analytical step is transparent and defensible. ResolveMass Laboratories Inc. provides sponsors with a trusted, scientifically advanced partner capable of supporting global submissions and long-term product safety.
👉 Contact ResolveMass Laboratories
FAQs About ICH Q3E Extractables & Leachables (E&L) Testing
It is the scientific evaluation of substances that may migrate from materials into drug products. ICH Q3E ensures that these impurities remain controlled, helping protect patient safety and meeting global regulatory expectations.
E&L testing provides a detailed impurity profile, supports risk assessments, and delivers documentation aligned with ICH and USP standards. This helps sponsors present complete and defensible data during regulatory submissions.
The Analytical Evaluation Threshold (AET) is the lowest concentration at which a detected compound requires toxicological assessment. It guides targeted analysis and supports compliance with ICH Q3E requirements.
ResolveMass offers advanced instrumentation, multi-matrix expertise, and complete regulatory support. Their structured approach ensures accurate studies and stronger submission packages.
ISO 10993-18 focuses on the chemical characterization of medical device materials. It works alongside ICH Q3E when products involve device components or blended material systems.
These results support impurity profiling, safety evaluations, and risk documentation required by agencies such as FDA, EMA, and Health Canada. Clear reporting helps streamline the review process.
References
- Balfour, H. (2022, April 29). Advancing extractables and leachables testing. European Pharmaceutical Review. https://www.europeanpharmaceuticalreview.com/article/170814/advancing-extractables-and-leachables-testing/
- Rozio, M. G. (2025). Correcting detection and quantitation bias in extractables and leachables testing. Journal of Pharmaceutical Analysis, 15(2), 123–134. https://doi.org/10.1016/j.jpha.2025.04.004
- United States Pharmacopeial Convention. (n.d.). Extractables and leachables. Retrieved October 10, 2025, from https://www.usp.org/impurities/extractables-and-leachables
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