Top Questions About E&L Testing Answered 

Extractables and leachables are substances that can be released from packaging, containers, or delivery systems into a drug or medical product. Extractables are identified under intense lab conditions, simulating worst-case scenarios. Leachables, however, are detected during normal storage or usage and may enter the final product over time.
Understanding the role of E&L testing helps you avoid health risks, ensure compliance, and improve product quality. At ResolveMass, we offer tailored solutions that adapt to your product’s materials and contact types.
Get Started with Professional Testing: Explore our Extractables and Leachables Testing Services

Health authorities like the FDA, EMA, and USP require E&L testing to protect patients and ensure the stability of drug products. When materials release unsafe chemicals, they can affect the drug’s safety, purity, and effectiveness. That’s why E&L testing is not just a recommendation—it’s a regulatory must.
Besides meeting legal standards, this testing shows your dedication to product safety and boosts confidence among healthcare providers. At ResolveMass, we strictly follow globally recognized guidelines such as USP <1663>/<1664> and ISO standards.
Navigate Compliance Standards: Learn about USP Extractables and Leachables Guidelines

Any medical or pharmaceutical product that touches packaging or delivery systems may require E&L testing. These include:
Nasal sprays and inhalers
Injectable drugs (ampoules, vials, prefilled syringes)
Implantable devices
IV tubing and reservoirs
Plastic packaging for pharmaceuticals
Each product category comes with unique risks. That’s why ResolveMass offers testing strategies based on how your product is used and how long it’s in contact with its container.
Specialized Device Testing: E&L Testing for Medical Devices

When performing E&L testing, it’s crucial to follow the right industry rules. At ResolveMass Laboratories, we work within these globally accepted standards:
USP <1663> and USP <1664>
ICH Q3D (elemental impurities)
ISO 10993 (medical devices)
FDA and EMA guidance documents.
Ensure Global Compliance: ISO 10993-18 E&L Testing Services

The best time to start E&L testing is early in the product development cycle. Ideal stages include:
Choosing materials and packaging
Before starting preclinical or clinical trials
During stability testing
Before filing for regulatory approval
You should also repeat the testing if you change the formulation or container. Starting early saves time and avoids delays later in the approval process.
Accelerate Your Submission: E&L Testing for Regulatory Submission

We use top-tier scientific tools to detect both organic and inorganic extractables and leachables. These include:
GC-MS for volatile compounds
LC-MS for semi-volatile and non-volatile compounds
ICP-MS for metals and elemental analysis
FTIR, UV, TOC, and NMR for broader profiling
Every method we use is tailored to your product’s unique needs. That means better results and smoother approvals.

E&L testing costs can vary depending on your product and the complexity of the test. Factors include:
Type of drug (inhalable, injectable, etc.)
Number of materials involved
Depth of toxicology evaluation required
At ResolveMass, we believe in clear pricing. We offer custom packages with no hidden charges—just honest value for your investment.
Budget-Friendly Safety: Affordable E&L Testing Solutions

At ResolveMass Laboratories, we bring a deep understanding of extractables and leachables along with unmatched customer support. Here’s why clients choose us:
Long history in E&L testing
Compliance with all global regulations
Fast turnaround and secure data handling
Friendly, expert project managers
Tailored testing based on product risk
We’re more than a service provider—we’re your partner in delivering safe, high-quality healthcare solutions.

ResolveMass Laboratories Inc. offers extractables and leachables (E&L) testing services designed for pharmaceutical and device-related programs. We support study design, analytical execution, and clear reporting that fits regulated development needs. Our focus is on actionable data—what’s present, how much, and what it means for product safety.

ResolveMass Laboratories Inc. offers extractables and leachables (E&L) testing services designed for pharmaceutical and device-related programs. We support study design, analytical execution, and clear reporting that fits regulated development needs. Our focus is on actionable data—what’s present, how much, and what it means for product safety.

ResolveMass Laboratories Inc. supports Canadian clients with E&L testing programs through streamlined sample shipping and project coordination across Canada. We help teams in Canada access full E&L capability without building in-house infrastructure. Deliverables are prepared for quality review and regulatory use.

ResolveMass Laboratories Inc. provides E&L testing for pharmaceuticals, including oral solids, liquids, and parenteral products. We evaluate packaging, delivery systems, and process-contact materials to identify and quantify potential migrants. Results are formatted to support risk-based decisions and filing requirements.

ResolveMass Laboratories Inc. specializes in E&L testing for medical devices by characterizing extractables from polymers, elastomers, and assemblies under controlled conditions. We generate chemical profiles and identify key compounds relevant to patient exposure. The output supports device safety evaluations and documentation packages.

You can outsource container closure E&L studies to ResolveMass Laboratories Inc., covering vials, stoppers, seals, bottles, and associated components. We build study designs that match intended use and product contact conditions. Reporting highlights critical leachables and supports closure qualification activities.

ResolveMass Laboratories Inc. performs E&L testing aligned with USP <1663> and USP <1664> expectations, including structured extractables studies and targeted leachables follow-up. We document solvents, conditions, and analytical justification in an audit-ready manner. This helps sponsors demonstrate a defensible E&L rationale.

ResolveMass Laboratories Inc. offers E&L analysis using complementary platforms such as LC–MS, GC–MS, and ICP–MS to cover organics, volatiles/semi-volatiles, and elemental impurities. We select techniques based on material type, risk, and required sensitivity. This multi-platform approach improves coverage and confidence in identification.

ResolveMass Laboratories Inc. supports toxicological risk assessment for leachables by translating analytical results into exposure-focused, safety-relevant interpretations. We help prioritize compounds, define reporting thresholds, and build a clear justification for next steps. Outputs are structured for inclusion in regulatory narratives and internal QRM.

ResolveMass Laboratories Inc. provides E&L testing for combination products by evaluating drug-device interfaces, flow paths, and patient-contact components. We tailor extraction conditions to mimic realistic use and stress scenarios. The resulting package supports both product safety and development decision-making.

ResolveMass Laboratories Inc. supports E&L studies for biologics and injectables with methods and sample handling suited for sensitive matrices. We focus on minimizing interferences while maintaining low-level detection for relevant leachables. Reports are designed to support parenteral risk assessments and filing needs.
Industry-Specific Expertise: Extractables and Leachables in Biopharma

ResolveMass Laboratories Inc. provides extractables profiling for packaging materials such as plastics, elastomers, and multilayer films. We generate comprehensive chemical fingerprints and identify key extractables that may translate into leachables. This helps sponsors compare suppliers, qualify materials, and reduce downstream surprises.
Custom Research Design: Custom E&L Study Design Services

ResolveMass Laboratories Inc. offers leachables testing under accelerated stability conditions to understand worst-case migration and time-dependent trends. We can align timepoints with stability protocols and present results in a trend-friendly format. This supports faster risk decisions during development and tech transfer.
Comprehensive Matrix Testing: Multi-Matrix E&L Testing Services

ResolveMass Laboratories Inc. provides regulatory support for E&L submissions by delivering clear study rationales, method summaries, and defensible conclusions. We format reports to be easy to reference in CMC sections and respond to common reviewer questions. The goal is fewer loops and faster approval pathways.
Regulatory Compliance: Extractables and Leachables FDA Guidance

ResolveMass Laboratories Inc. supports E&L testing for syringes and IV bags, including contact materials, adhesive zones, and fluid path components. We design studies around realistic fill solutions and storage/use conditions. Outputs help qualify systems for patient safety and compatibility.

ResolveMass Laboratories Inc. performs extractables screening for polymer-based materials using solvent systems and conditions matched to risk and intended use. We identify and semi-quantify compounds to build a practical extractables list for follow-up. This supports supplier qualification and material selection.

ResolveMass Laboratories Inc. provides unknown compound identification in E&L studies using high-information mass spectrometry workflows and structured data interpretation. We prioritize unknowns based on abundance and safety relevance, then document identification confidence. This reduces uncertainty and strengthens the final risk narrative.
Toxicology & Safety: Extractables and Leachables Carcinogenicity Testing

ResolveMass Laboratories Inc. offers E&L testing with method validation or fit-for-purpose qualification, depending on program stage and regulatory need. We define performance characteristics such as specificity, sensitivity, accuracy, and precision where applicable. Validation documentation is delivered in a quality-friendly format.

ResolveMass Laboratories Inc. supports E&L testing for NDA and ANDA filings with study plans and reports built for regulatory review. We align testing scope to product type, packaging configuration, and risk level. Deliverables are structured to integrate smoothly into filing modules and responses.

ResolveMass Laboratories Inc. offers end-to-end E&L programs, from protocol strategy and extraction design through analytics, identification, and risk-based conclusions. We coordinate multi-technique testing so the dataset is coherent and submission-ready. This reduces handoffs and keeps accountability in one place.
Full-Service Solutions: Extractable and Leachable (E&L) Services

ResolveMass Laboratories Inc. supports fast regulatory timelines by prioritizing study setup, clear sampling requirements, and streamlined reporting workflows. We help clients choose efficient study designs that still meet defensibility expectations. When timelines are tight, we focus on clarity, speed, and data integrity together.

Yes, E&L testing is mandatory or highly recommended for any product that comes in contact with its container or delivery system. Regulatory agencies like the FDA and EMA expect this data during submissions. Without proper E&L testing, your product could face delays or rejection.

Common extractables and leachables include plasticizers like DEHP, antioxidants, slip agents, monomers, and heavy metals. These substances can leach from plastic or rubber components into the drug product. Identifying them early is key to avoiding health risks.

Not all leachables are automatically harmful, but they must be evaluated through toxicological risk assessments. Experts look at safety thresholds such as TTC (Threshold of Toxicological Concern) and PDE (Permitted Daily Exposure) to determine potential impact on patients.

Yes, poor-quality or incomplete E&L data is one of the main causes of regulatory delays. Agencies may request retesting or clarification, which can slow down product approval. Working with a trusted lab like ResolveMass ensures your data is submission-ready.

No, E&L testing and stability testing serve different purposes. Stability testing checks how long a product remains effective over time, while E&L testing focuses on identifying chemicals that migrate from packaging materials. Both are essential for safety.

You’ll receive a full analytical and toxicological report, formatted to meet regulatory submission requirements such as IND, NDA, ANDA, and 510(k). The report includes detailed results, risk assessments, and method validation summaries tailored to your product.

Simulation testing uses harsh solvents to extract potential compounds under extreme conditions, mimicking worst-case scenarios. Real-use testing, on the other hand, evaluates chemical migration under normal storage and usage conditions. Both methods provide essential insights.