Selecting the right laboratory for E&L Testing in the United States is one of the most important steps for pharmaceutical, biopharma, and medical device manufacturers. The accuracy, reliability, and compliance of extractables and leachables studies directly affect product safety, regulatory approval, and market timelines. Even a small oversight can cause costly delays or product recalls. This guide explains how to identify the right laboratory partner that blends technical skill with strong regulatory knowledge while helping you make confident, well-informed decisions.
Summary of the Article
- Understand the fundamentals and importance of E&L Testing in the United States
- Identify key criteria for evaluating E&L testing laboratories
- Learn how to assess analytical capabilities, regulatory insight, and data reporting
- Recognize the value of customized study design and fast turnaround times
- Explore the advantages of working with ResolveMass Laboratories Inc.
- Discover common mistakes to avoid when selecting a testing partner
- Review detailed FAQs for scientists and regulatory professionals
These points act as a roadmap for manufacturers and regulatory teams aiming to achieve global compliance and efficient testing outcomes.
What Is Extractables and Leachables (E&L) Testing and Why It Matters
E&L Testing in the United States ensures that packaging, medical devices, or drug product materials do not release unsafe chemicals under actual usage conditions. “Extractables” are compounds released under harsh conditions, while “leachables” are the substances that migrate into the product during normal use or storage.
The purpose of E&L testing is to protect patient safety and maintain compliance with FDA, USP, and ISO 10993-18 standards. Reliable testing prevents recalls, accelerates approvals, and builds trust in the compatibility and long-term stability of pharmaceutical products.
👉 Learn more: Extractable and Leachable E&L Services
1. Expertise and Experience – The Foundation of Reliable E&L Testing in the United States
When selecting a laboratory for E&L Testing in the United States, prioritize experience across both pharmaceutical and medical device sectors. A qualified lab should have a multidisciplinary team skilled in chemistry, toxicology, and materials science, along with a strong regulatory background.
An experienced laboratory demonstrates successful FDA and USP submissions, follows ISO 10993-18 and USP <1663>/<1664> guidelines, and delivers scientifically defensible data. ResolveMass Laboratories exemplifies these qualities, providing dependable extractables, leachables, and controlled extraction studies that consistently meet regulatory expectations.
👉 Read more: ISO 10993-18 E&L Testing
2. Analytical Capabilities and Advanced Instrumentation for E&L Testing
Analytical precision defines the strength of any E&L testing laboratory. Leading labs use technologies such as LC-MS, GC-MS, ICP-MS, and FTIR to detect both organic and inorganic extractables. These tools ensure a complete understanding of chemical profiles and uncover even trace contaminants.
Checklist for Analytical Evaluation:
- Multi-technique platform (LC-MS/MS, GC×GC-MS, ICP-MS, TOC)
- Detection limits at sub-ppb levels
- Validated in-house reference libraries
- Capability to test multiple material matrices
Advanced instrumentation enables confident regulatory submissions, eliminating risks of incomplete data and enhancing overall product safety.
👉 Explore details: Analytical Techniques for E&L Testing
3. Regulatory Knowledge and Compliance Support
An effective E&L Testing in the United States partner must demonstrate strong regulatory insight. The best laboratories align their studies with:
- FDA Guidance for Industry
- USP <1663> and <1664> requirements
- ISO 10993-18 standards
Regulatory-aligned testing reduces noncompliance risks and accelerates approval timelines. ResolveMass Laboratories provides submission-ready reports that meet U.S. and global standards, ensuring consistent support for multinational regulatory filings.
👉 Reference: E&L Testing for Regulatory Submission
👉 Learn more: Extractables and Leachables FDA Guidance
4. Custom Study Design and Flexibility in E&L Testing
Every product has unique materials and exposure conditions, which require a customized E&L testing strategy. Custom-designed studies allow realistic simulation of real-world scenarios and accurate risk assessments.
Key Components of Custom E&L Studies:
- Simulation of product use conditions
- Controlled extraction parameters (temperature and solvent)
- Multi-matrix analysis for different materials
ResolveMass Laboratories tailors every study to match client goals, product type, and regulatory needs. This flexibility also supports revalidation when materials or formulations change, saving both time and resources.
👉 Explore: Custom E&L Study Design Services
👉 Related: Controlled Extractables Study
5. Turnaround Time and Cost Transparency
Efficiency and cost clarity are essential when selecting a lab for E&L Testing in the United States. Quick results ensure manufacturers meet submission deadlines while maintaining product quality. Reliable labs communicate timelines clearly, provide upfront cost structures, and adapt to project needs.
ResolveMass Laboratories delivers fast, high-quality results without compromising accuracy. Transparent pricing, flexible study packages, and a streamlined workflow minimize delays and prevent hidden expenses.
👉 Learn more: Cost of E&L Testing
👉 See: Fast E&L Testing Services
6. Reporting Quality and Data Interpretation
High-quality documentation is key to regulatory approval. Reports should contain executive summaries, analytical data, chromatograms, and toxicological evaluations presented in an organized and easy-to-follow manner.
Strong reporting not only helps regulatory reviewers but also reflects the laboratory’s commitment to transparency and accuracy. ResolveMass Laboratories provides comprehensive, audit-ready reports that withstand scrutiny from both internal QA and external regulatory audits.
7. Why Choose ResolveMass Laboratories Inc.
ResolveMass Laboratories Inc. is a trusted provider of E&L Testing in the United States, known for combining regulatory insight with advanced analytical methods.
Their strengths include:
- In-depth regulatory and analytical expertise
- FDA- and USP-aligned methodologies
- Rapid turnaround times and cost efficiency
- Transparent project communication
- Proven ISO 10993-18 compliance
ResolveMass’s client-centric approach ensures seamless communication, customized study plans, and consistent updates throughout the testing process. By maintaining scientific excellence and reliability, ResolveMass has become a preferred partner for leading pharmaceutical and medical device companies.
👉 Learn more:
E&L Testing FAQs
E&L Testing for Medical Devices
USP Extractables and Leachables
Affordable E&L Testing Solutions
8. Common Mistakes to Avoid When Selecting a Laboratory
| Mistake | Impact | How ResolveMass Prevents It |
|---|---|---|
| Choosing based on price only | May compromise data quality | Offers affordable yet validated testing |
| Ignoring regulatory expertise | Causes submission delays | Provides regulatory-ready reports |
| Overlooking analytical depth | Leads to missed impurities | Uses advanced instrumentation |
| Not verifying lab accreditation | Results in non-compliance | Maintains ISO and GLP-certified systems |
Many companies make these errors, often focusing only on cost or timelines. Avoiding these pitfalls ensures smoother submissions, fewer data gaps, and faster regulatory success. Partnering with ResolveMass Laboratories guarantees consistent quality and full compliance.
Conclusion
Choosing the right partner for E&L Testing in the United States means finding a balance between analytical excellence, regulatory expertise, and operational reliability. ResolveMass Laboratories Inc. brings all these strengths together, offering dependable, submission-ready results that protect patients and accelerate product launches. With state-of-the-art technology and deep scientific understanding, ResolveMass continues to set the standard for extractables and leachables testing in the industry.
👉 Connect with our experts today: Contact Us
Frequently Asked Questions (FAQs)
Modern E&L laboratories rely on highly sensitive instruments such as LC-MS/MS, GC-MS, ICP-MS, and FTIR. These technologies enable the detection of even trace-level impurities across multiple materials. Such advanced analytical tools ensure that every compound is identified, providing complete assurance of product safety and regulatory readiness.
Regulatory agencies like the FDA, USP, and ISO have established clear guidelines for E&L evaluations. Standards such as USP <1663>, USP <1664>, and ISO 10993-18 define the proper methods and acceptance criteria for extractables and leachables testing. Adhering to these ensures compliance and facilitates smoother global product submissions.
Yes. ResolveMass Laboratories specializes in multi-matrix E&L studies that assess various materials such as polymers, glass, elastomers, and metals. This approach ensures a complete understanding of how each component interacts with the product, supporting comprehensive safety evaluations and robust regulatory submissions.
Toxicological evaluation is an essential step in interpreting analytical data. It involves comparing detected compound concentrations against thresholds like the Analytical Evaluation Threshold (AET). This process ensures that identified extractables and leachables do not pose toxicological risks to patients or end-users.
References
- 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
- Balfour, H. (2022, April 29). Advancing extractables and leachables testing. European Pharmaceutical Review. https://www.europeanpharmaceuticalreview.com/article/170814/advancing-extractables-and-leachables-testing/
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