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Extractables & Leachables for Pharmaceuticals

pharma-extractables-leachables

What unseen risks are leaching into your pharmaceutical product — and could they threaten patient safety or delay regulatory approval?

In the tightly regulated world of pharmaceuticals, ensuring that packaging materials, container-closure systems, and delivery devices do not compromise product safety is non-negotiable. That’s where extractables and leachables (E&L) testing becomes critical. From early-stage development to commercial launch, E&L studies help identify and quantify chemical compounds that may migrate into drug formulations — and are a cornerstone of compliance with USP <1663>, USP <1664>, FDA, EMA, and PQRI expectations.

At Nelson Labs, we deliver comprehensive extractables and leachables testing tailored to the pharmaceutical industry’s evolving regulatory landscape. With proprietary analytical methods, a library of over 1,000 reference compounds, and global lab capabilities, we help you navigate complexity, avoid delays, and protect patient health. Whether you’re developing a novel biologic, working with complex delivery systems, or preparing for submission, our expert team ensures that your product stands up to scrutiny — and reaches the market with confidence.

What Are Extractables and Leachables – And Why Do They Matter in Pharma?

When it comes to pharmaceutical product safety, the materials surrounding your drug can be just as important as the active pharmaceutical ingredient itself. Packaging components, closure systems, and delivery devices can release trace chemicals—often unnoticed—into the drug product. That’s where extractables and leachables testing plays a crucial role.

Extractables are chemical compounds that can be forcibly released from a material under aggressive laboratory conditions such as high temperature, solvents, or prolonged exposure. They represent a worst-case scenario and are typically identified during an extraction study early in the development process.

Leachables, on the other hand, are compounds that migrate into the drug product under normal storage or usage conditions. These are the compounds that patients may ultimately be exposed to—making their detection and toxicological evaluation essential for regulatory submissions and patient safety.

Both extractables and leachables can originate from:

  • Primary packaging materials
  • Delivery systems (e.g., pre-filled syringes, inhalers)
  • Manufacturing equipment
  • Container-closure systems

Failing to identify and quantify these compounds can result in:

  • Batch failures or delays in product release
  • Non-compliance with USP <1663> / <1664> or FDA/EMA guidance
  • Risk to patient health due to potential toxicity or drug instability

That’s why global regulatory authorities—including the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Product Quality Research Institute (PQRI)—mandate robust E&L testing as part of their quality and safety expectations.

At Nelson Labs, we guide you through both extractables and leachables studies, helping you identify, assess, and mitigate risk early—so you can move confidently through the development process and avoid costly setbacks.

Our E&L Testing Capabilities and Approach

Pharmaceutical companies rely on Nelson Labs not just for regulatory compliance — but for scientific clarity, speed, and confidence at every stage of development. Our extractables and leachables testing services are designed to support a full range of drug products and packaging systems, including parenterals, inhalables, biologics, and complex combination products.

We take a comprehensive, risk-based approach that integrates both chemical analysis and toxicological evaluation — ensuring your product meets global regulatory requirements and withstands scrutiny from health authorities.

Full-Service E&L Workflow — From Material to Market

Our E&L studies follow a structured yet flexible workflow tailored to your product’s specific risk profile:

  • Material Review & Risk Assessment
     Early-stage material evaluation to identify potential sources of leachables
  • Extraction Study Design
     In line with USP <1663> and PQRI best practices, including solvent selection, temperature, duration, and surface area considerations
  • Advanced Analytical Testing
     Screening and quantification of volatile, semi-volatile, and non-volatile compounds
  • Leachables Simulation & Confirmatory Studies
     Leachables profiling under real-time or accelerated stability conditions
  • Toxicological Risk Assessment
     In-house or partner toxicologists assess safety thresholds (e.g., AET, SCT, TTC)
  • Regulatory Report Generation
     Submission-ready documentation aligned with FDA, EMA, and ICH expectations

Our risk-based study designs align with ICH Q9 and Q3E principles to ensure appropriate testing without unnecessary delays or cost.

Advanced Instrumentation for E&L Studies

Nelson Labs utilizes a full suite of validated analytical technologies to support even the most complex formulations and packaging systems:

  • Gas Chromatography / Mass Spectrometry (GC/MS, HS-GC/MS)
     For identification of volatile and semi-volatile compounds
  • Liquid Chromatography / Tandem Mass Spectrometry (LC-MS/MS)
     Ideal for polar, non-volatile extractables and degradation products
  • Inductively Coupled Plasma – Mass Spectrometry (ICP-MS)
     For elemental impurities per ICH Q3D and metal leachables
  • Nuclear Magnetic Resonance (NMR)
     For structural elucidation and unknown compound identification
  • Ion Chromatography (IC) and Total Organic Carbon (TOC)
     For ionic and low-level organic contaminants

Every analysis is backed by our proprietary chemical library of 1,000+ reference standards — enabling faster identification and greater confidence in unknown compounds.

This holistic approach to extractables and leachables testing helps you:

  • Reduce risk of late-stage product failure
  • Meet global submission requirements with confidence
  • Maintain product quality and patient safety throughout the product lifecycle

Regulatory Alignment You Can Trust

Navigating extractables and leachables (E&L) requirements isn’t just about generating data — it’s about generating the right data, in the right format, for the right regulatory body. At Nelson Labs, we don’t just perform testing. We help you build a compliance strategy grounded in current expectations from global health authorities.

Our E&L study designs are tailored to meet — and often exceed — the standards set by:

USP <1663> and USP <1664> Guidelines

The United States Pharmacopeia outlines industry-accepted practices for extractables and leachables testing in pharmaceutical packaging systems and delivery devices:

  • USP <1663>: Scientific principles and best practices for conducting extractables studies
  • USP <1664>: Guidance for designing and interpreting leachables studies based on simulated or real-use conditions

Nelson Labs adheres strictly to these guidelines, using scientifically justified methods and validated protocols that align with product-specific requirements.

FDA and EMA Expectations

We’ve supported hundreds of E&L studies submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Our reports are designed with agency reviewers in mind, including:

  • Full documentation of analytical conditions and findings
  • Toxicological evaluations using recognized thresholds (e.g., Safety Concern Threshold, Threshold of Toxicological Concern)
  • Clear justification for analytical limits, extractables simulation conditions, and compound selection

Need a submission-ready extractables and leachables report? Our team ensures that your documentation meets regional formatting and content expectations.

PQRI Recommendations and Risk-Based Testing

We also follow Product Quality Research Institute (PQRI) guidance — especially relevant for orally inhaled and nasal drug products (OINDP), injectable drug products, and container-closure systems.

  • Use of Analytical Evaluation Thresholds (AETs) to guide reporting
  • Application of Safety Concern Thresholds (SCTs) and Qualification Thresholds (QTs)
  • Risk-based reduction of unnecessary testing through scientific justification

Our subject matter experts are well-versed in balancing risk with regulatory expectations — ensuring that your E&L testing is neither under- nor over-scoped.

ICH and ISO Integration

  • ICH Q3D: For elemental impurities, often used in parallel with extractables testing
  • ICH Q9 / Q3E: Risk-based approaches to pharmaceutical development and impurity qualification
  • ISO 10993-18: For combination products and device–drug interfaces

By integrating these global frameworks, we ensure your program supports international submissions and aligns with the future direction of pharmaceutical regulation.

Let Regulatory Confidence Be Your Competitive Advantage

With regulations tightening across the globe — and growing scrutiny over materials and leachables — proactive E&L testing is no longer optional. It’s a strategic necessity.

Nelson Labs provides more than data. We provide interpretation, documentation, and expert support tailored to your product’s route of administration, dosage form, and risk profile — so you can move through regulatory review with confidence.

What Sets Nelson Labs Apart

In a field as regulated and technically complex as extractables and leachables testing, choosing the right partner can mean the difference between submission success and costly delays. At Nelson Labs, we go beyond compliance checklists — offering scientific insight, global reach, and unmatched analytical resources that help our clients achieve both regulatory confidence and market advantage.

Proprietary Chemical Library for Faster, More Accurate Results

Unknown compounds are one of the biggest causes of regulatory pushback in E&L submissions. That’s why we’ve built and maintained a proprietary library of over 1,000 analytically verified reference compounds — giving you:

  • Faster identification of unknowns during screening
  • Greater confidence in structural elucidation
  • Reduced turnaround time from analysis to reporting

Our library evolves in parallel with changes in packaging materials and polymer formulations — so we stay ahead of new extractable trends.

Global Laboratory Network for Streamlined Study Execution

With testing laboratories in the U.S. and Europe, Nelson Labs offers multinational clients a unified experience — wherever your drug product is developed or manufactured. Our global infrastructure enables:

  • Coordinated E&L studies across regions
  • Harmonized methods and reporting formats
  • Localized regulatory expertise for FDA, EMA, and beyond

One partner, multiple continents — and consistent data integrity wherever your operations are based.

Integrated Toxicological Support for Regulatory Submission

Toxicological interpretation is often the most challenging and scrutinized part of an E&L program. Nelson Labs offers in-house and partner toxicologists who:

  • Evaluate compound risk against TTC, SCT, and PDE thresholds
  • Assist in defining Analytical Evaluation Thresholds (AETs)
  • Provide data-driven recommendations for qualification or risk mitigation

This ensures your submission isn’t just chemically sound — it’s toxicologically defensible.

Expertise with Emerging Packaging Systems & Biologics

From pre-filled syringes and biologic delivery devices to single-use systems (SUS) and advanced polymer containers, we support some of the most innovative and high-risk delivery formats in the industry.

Our scientists understand the unique E&L challenges presented by:

  • High-surface-area or complex geometries
  • Sensitive biologic formulations
    Closed-loop or dual-chamber systems

We combine materials science, regulatory insight, and method development expertise to tailor studies that meet the needs of your product — not just the letter of the guideline.

End-to-End Support — From Feasibility to FDA Submission

Whether you’re in early development or preparing a final dossier, our team provides support throughout your journey:

  • Study design consulting
  • Analytical protocol creation
  • Data interpretation meetings
  • Submission-ready reports
  • Responses to agency questions or feedback

Your success is our focus — from first material review to final product launch.

CTA: “Learn how our proprietary library and expert team can streamline your submission process. Request a Quote.”

Educational Resources

Regulatory expectations and analytical technologies in extractables and leachables testing are constantly evolving. That’s why Nelson Labs offers a wide range of resources to help pharmaceutical professionals stay informed, compliant, and prepared for agency scrutiny.

Whether you’re new to E&L testing or seeking clarification on recent guideline updates, our resources are designed to answer your questions — and prepare your team for success.

On-Demand Webinars

Gain insight directly from our scientific experts through recorded webinars that cover real-world applications and case studies in extractables and leachables testing.

Featured Webinar
 A Risk-Based Approach Towards the Assessment of Process Equipment-Related Leachables (PERLs)
 Watch now →

Topics covered:

  • PERLs and their regulatory implications
  • How to evaluate leachables from single-use systems
  • Risk mitigation strategies in early development

Ideal for: Quality assurance leads, regulatory affairs professionals, and formulation scientists.

Whitepapers and Technical Articles

Explore in-depth content written by Nelson Labs subject matter experts, including:

Available for download — ideal for internal education or inclusion in cross-functional strategy planning.

E&L Testing FAQs

  • What’s the difference between extractables and leachables?
  • How long does an E&L study typically take?
  • What’s included in a submission-ready E&L report?
  • How do regulations differ between the FDA and EMA?

FAQs About Extractables & Leachables Testing

What’s the difference between extractables and leachables?

Extractables are compounds that can be forced out of packaging or delivery system materials when exposed to aggressive laboratory conditions (heat, solvents, extended time). They represent a “worst-case” profile of what a material could release.

Leachables, by contrast, are compounds that actually migrate into the drug product under normal storage, shelf life, or patient-use conditions. These compounds pose the greatest concern because they can affect patient safety, drug quality, and regulatory approval.

How long does an E&L study typically take?

The timeline depends on study scope, product type, and regulatory requirements. On average:

  • Extractables studies: typically 8–12 weeks, including method development, extraction, and analysis.
  • Leachables studies: often conducted in parallel with stability studies and may take 3–12 months, depending on product shelf life.

At Nelson Labs, we design studies with efficiency in mind, using risk-based approaches and proprietary reference libraries to minimize delays without compromising compliance.

What’s included in a submission-ready E&L report?

A regulatory-compliant E&L report from Nelson Labs typically includes:

  • Study protocol and justification (aligned with USP <1663>, <1664>, PQRI, FDA/EMA guidance)
  • Analytical methods and conditions used for detection and quantification
  • Complete list of detected compounds, including identification and concentrations
  • Toxicological risk assessment (AET, SCT, PDE evaluations)
  • Data interpretation: what the results mean for patient safety and compliance
  • Clear, regulator-friendly formatting to support FDA, EMA, and other agency submissions

Our reports are prepared to answer likely reviewer questions, reducing back-and-forth during the submission process.

How do regulations differ between the FDA and EMA?

Both the FDA and the EMA require extractables and leachables testing, but there are differences in emphasis and approach:

  • FDA: Focuses heavily on safety thresholds, toxicological justification, and risk-based testing. Submission reports must clearly link analytical findings to toxicological evaluations.
  • EMA: Places more emphasis on compliance with established guidelines such as PQRI recommendations for OINDP and injectables, and expects detailed reporting of both extractables and leachables profiles.
  • Both agencies expect alignment with USP <1663>/<1664> and ICH principles, but specific documentation preferences may differ.

Nelson Labs designs studies with both agencies in mind, ensuring your data package is versatile enough for global submissions.

Ensure Product Safety and Regulatory Success with Nelson Labs

Extractables and leachables testing isn’t just a regulatory box to check — it’s a safeguard for patient safety, drug stability, and your organization’s reputation. With the right partner, you can reduce risk, streamline submissions, and bring products to market with confidence.

At Nelson Labs, we combine state-of-the-art instrumentation, a proprietary chemical library, and global regulatory expertise to deliver more than just data. We deliver insights, strategy, and submission-ready documentation that help you move forward without costly delays.

Ready to Begin Your E&L Testing Program?

  • Speak directly with our scientific experts
  • Request a tailored extractables and leachables study design
  • Ensure your data package meets FDA, EMA, USP, and PQRI requirements

CTA: Request a Quote or Contact Us Today →

Your innovation deserves a clear path to approval. Nelson Labs will help you get there.

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