Introduction
When pharmaceutical and biotechnology companies seek Extractables and Leachables (E&L) testing services , one aspect is to have idea about the cost of Extractables and Leachables (E&L) testing. The cost of extractables and leachables testing is an depends on few major critical parameters such as Type of Container Closure system or delivery system, No. of components involved, Scope of E&L Testing, Analytical Techniques employed (GCMS, LCMS, ICPMS), Regulatory expectation and finally the method development criticality. In this article, we provide comprehensive information on all the above parameters, so that informed decision-making and cost-effective strategies can be achieved.
For organizations evaluating a vendor for E&L studies, ResolveMass Laboratories Inc. offers industry-leading analytical services that combine technical depth, regulatory compliance, and flexible pricing models. Learn more about our Extractables and Leachables Testing Services.
Why E&L Testing is Crucial in Pharmaceuticals
E&L testing ensures that any potentially harmful chemicals that migrate from packaging or manufacturing components into the drug product are identified and quantified. Regulatory agencies such as the FDA, EMA, and Health Canada require rigorous extractables and leachables testing to mitigate patient safety risks.
The cost of extractables and leachables testing can vary significantly depending on multiple parameters, which we explore below.
Also, if you want to learn in detail factors about various factors for Choosing the Best Lab for Extractables and Leachables (E&L) Testing in Montreal, Canada, or the United States.
Key Factors That Affect the Cost of Extractables and Leachables Testing
1. Type of Container or Delivery System
The container closure system or drug delivery device directly affects the cost of extractables and leachables testing. Complex systems like inhalers, pre-filled syringes, and transdermal patches require more extensive studies than simple glass vials. so first factor to be identified by the client is the identification of Container closure system.
2. Scope of Extractables vs. Leachables Studies
Extractables studies are typically conducted under exaggerated conditions, while leachables studies are done under real-time or accelerated stability conditions. Sometimes, the minor components observed below thresold values in Extractable study are leachables which needs to be identificed.
Explore our expertise in customized studies at ResolveMass E&L Testing Services.
3. Analytical Techniques Employed
Sometimes, it doesnot require to utilize all the instrument techniques, this can significantly reduce the overall E&L testing cost as the method development and instrument usage for that particular instrument would be reduced. Advanced techniques include:
- GC-MS: for volatile and semi-volatile organic compounds
- LC-MS/MS: for non-volatile compounds
- ICP-MS: for elemental impurities
- FTIR and UV-Vis: for material identification
To know more about these techniques, checkout our detailed article.
- Sometimes, microbilogical tests such as cytotoxicity, Hemocompatibility, Systemic Toxicity, Endotoxin Testing are also required as part of E&L Testing. This adds the cost of E&L testing.
Using multiple platforms for orthogonal confirmation increases both reliability and price.
4. Number of Components and Contact Materials for Cost of Extractables and Leachables Testing
More components in a system—stoppers, plungers, laminates, adhesives—mean more testing. This adds to sample prep time, extraction media, and analytical hours, clearly influencing the cost of extractables and leachables testing.
5. Regulatory Expectations and Submission Goals
Projects intended for regulatory submissions in the US, EU, or Canada often require customized protocols aligned with USP <1663> and <1664>, ISO 10993, and ICH Q3D. These require detailed documentation and QA oversight, increasing the cost of extractables and leachables testing.
We help clients navigate these frameworks at ResolveMass Laboratories.
6. Sample Throughput and Timelines for Cost of Extractables and Leachables Testing
Urgent timelines or parallel sample processing may require additional shifts, faster turnaround, or dedicated resources—all of which can increase the cost of extractables and leachables testing.
7. Method Development and Validation
New materials may need method development and validation, which is resource-intensive. For example, polymers with unknown extractables profiles may require LC-MS method development.
Get support with validated methods at ResolveMass’s E&L Testing Lab.
8. Reporting and Risk Assessment Support
Clients often require toxicological risk assessments, regulatory-ready reports, or justification packages. These scientific consulting services add value but can influence the cost of extractables and leachables testing.
If you want to learn more about Extractables and Leachables Testing in Canada: Best Practices for Risk Assessment
9. Quality Assurance and Data Integrity Protocols
21 CFR Part 11 compliance, electronic data transfer, and QA audit trails are crucial for GMP-compliant testing. Facilities with these capabilities offer reliable services—but the operational overhead may reflect in pricing.
Discover GMP testing infrastructure at ResolveMass Laboratories.
10. Batch Sizes and Number of Test Articles
Testing multiple batches or article replicates can add to extraction, analysis, and reporting workload—affecting the cost of extractables and leachables testing.
How to Budget Smartly for E&L Testing
- Request tiered pricing for different testing levels
- Start with an extractables-only study to assess risk before proceeding to full leachables
- Use existing method libraries where possible
- Bundle testing services for cost savings across stability, E&L, and container testing
- Communicate intended use early to avoid unnecessary testing
Learn how ResolveMass helps clients build cost-effective E&L testing plans: Explore Services.
Why Choose ResolveMass for E&L Testing
ResolveMass Laboratories Inc. brings:
- A proven track record in extractables and leachables testing for complex devices
- Access to cutting-edge instrumentation including LC-MS, GC-MS, and ICP-MS
- Compliance with USP <1663>, <1664>, and ISO 10993-18
- Responsive project management and detailed regulatory reporting
We’ve supported preclinical to commercial-stage programs with tailored E&L strategies that deliver quality insights and cost control.
Let us design your next E&L study: Request a Quote
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Conclusion
Understanding the cost of extractables and leachables testing is essential for pharmaceutical packaging and device developers. From component complexity to analytical techniques and reporting expectations, many factors shape the final price. Partnering with a knowledgeable lab like ResolveMass Laboratories ensures that your testing strategy is not only scientifically robust but also financially optimized.
Learn more about our E&L Testing Services or get in touch to request a quote today.
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ResolveMass Laboratories Inc.: Comprehensive Scientific Expertise You Can Rely On
ResolveMass Laboratories Inc. is a trusted Canadian contract research organization offering a wide spectrum of specialized services spanning polymer synthesis, advanced analytical testing, and custom organic synthesis. With over a decade of experience supporting pharmaceutical, biotech, and industrial clients, we bring scientific precision and regulatory insight to every project. Our core capabilities include Polymer Synthesis and Characterization, Peptide Characterization, Organic Synthesis, Nitrosamine Testing and Analysis, PFAS Testing, and Extractable & Leachable Studies, as well as a broad suite of analytical techniques such as HPLC, GC-MS, MALDI-TOF, NMR, and FTIR.
Our multidisciplinary team includes chemists, analytical scientists, and regulatory experts with advanced academic and industry backgrounds. We excel at developing customized, high-quality solutions—whether you need innovative polymer designs, impurity profiling, or confirmatory testing that meets global regulatory standards.
Clients across North America choose ResolveMass Laboratories for our deep technical knowledge, commitment to quality, and ability to deliver reproducible, reliable data that drives confident decision-making. When precision, innovation, and trust matter—ResolveMass is your partner of choice.
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