Extractables & Leachables (E&L) Testing Services Reduce Regulatory Risk, Prevent Delays, and Build Confidence in Your Product

When extractables and leachables risks are not addressed early, they can create major setbacks for pharmaceutical, medical device, and combination product programs. Unexpected compounds, incomplete study designs, uncertain regulatory expectations, and fragmented analytical workflows can all lead to costly delays, repeat testing, and added pressure during submissions.

CA Analytical Testing Services helps companies solve these problems with integrated E&L testing strategies designed to generate clear, defensible, regulatory-ready data. From early risk assessment through advanced analytical testing and reporting, we help clients move forward with greater speed and confidence.

E&L testing is rarely just a lab exercise. It often becomes a program-level challenge that affects timelines, budgets, and submission readiness.

Many organizations run into the same issues:

• E&L requirements are defined too late in development
• Study designs are incomplete or not aligned to product risk
• Internal resources lack the specialized instrumentation or expertise required
• Unknown compounds are difficult to identify and assess
• Methods are not sensitive enough for trace-level compounds
• Regulatory expectations are unclear or interpreted too late
• Data packages require rework before they are ready for review

The result is avoidable delay. Teams lose time troubleshooting problems that could have been prevented with a more strategic E&L approach from the start.

At CA Analytical Testing Services, we provide end-to-end E&L support to help clients reduce uncertainty and keep development moving. Our approach is built to solve the most common E&L pain points before they become larger regulatory or technical problems.

We help clients:

• define an E&L strategy early
• design studies that align with regulatory expectations
• identify and quantify extractables and leachables with the right analytical tools
• characterize unknown compounds with greater confidence
• develop robust, fit-for-purpose methods
• produce reporting that supports submissions and toxicological review

Rather than treating E&L as an isolated testing requirement, we integrate it into your broader development and compliance strategy.

Address leachables risk before it affects product quality, patient safety, or submission timelines

Pharmaceutical companies face significant pressure to demonstrate that packaging systems, single-use components, and manufacturing-contact materials do not introduce harmful compounds into the drug product. Even low-level leachables can raise concerns related to stability, safety, or regulatory acceptance.

Common pain points include:

• concern that packaging or process-contact materials may impact drug safety or stability
• nitrosamine or genotoxic impurity risk
• extremely low reporting thresholds and tight sensitivity requirements
• uncertainty around what is needed for IND, NDA, or ANDA support
• delays caused by incomplete data or weak study design

CA Analytical helps pharmaceutical clients address these issues through:

• extractables studies on packaging materials and single-use systems
• leachables studies under real-time and accelerated conditions
• nitrosamine analysis and ultra-trace impurity detection
• method development and validation aligned with ICH expectations
• support for toxicological risk assessment

Generate the chemical characterization data needed for biocompatibility and regulatory confidence

Medical device manufacturers are often challenged by complex materials, additives, processing aids, and unknown compounds that can affect biocompatibility assessments. Without well-designed E&L studies, it can be difficult to establish material safety or support ISO 10993 expectations.

Common pain points include:

• limited visibility into what compounds may be extracted from device materials
• difficulty identifying unknowns from polymers, coatings, and additives
• uncertainty around how E&L data connects to toxicological or biocompatibility evaluations
• pressure to support FDA and EU MDR submissions with stronger chemical characterization

Our medical device E&L capabilities include:

• controlled extractables studies for device materials
• simulated-use leachables studies
• support for ISO 10993-18 chemical characterization
• identification and quantification of unknown compounds
• integration with toxicological risk assessments

Manage the added complexity of drug-device interactions with a unified strategy

Combination products often create a unique E&L challenge because they sit between pharmaceutical and medical device expectations. Drug formulation, contact materials, delivery systems, and dual regulatory pathways can make study design significantly more complex.

Common pain points include:

• uncertainty around interactions between formulation and device materials
• difficulty aligning drug and device regulatory requirements
• repeated study revisions due to product complexity
• longer timelines caused by fragmented analytical support

CA Analytical supports combination product developers with:

• integrated E&L strategies for drug-device systems
• custom study designs based on product configuration and risk
• advanced analytical screening using targeted and non-targeted approaches
• support for submission strategies across global markets

Our workflow is built to reduce rework, improve clarity, and support faster decision-making throughout development.

We define the testing approach early so your team can avoid scope gaps, delays, and unnecessary repeat work later.

We apply the right platform for the compounds of interest, including:

• LC-MS, including high-resolution and triple quadrupole capabilities
• GC-MS for volatile and semi-volatile compounds
• ICP-MS for elemental impurities

We help reduce uncertainty with expert-driven structural elucidation and data interpretation, especially when unknown compounds create risk for development or submission.

We develop methods that are sensitive, robust, and aligned with the intended application and regulatory context.

We provide clear, defensible documentation designed to support toxicological review and regulatory submissions.

Clients come to us when they need more than test results. They need a partner that can help them solve technical and regulatory problems before those problems slow the program down.

CA Analytical Testing Services offers:

• end-to-end E&L expertise across pharmaceuticals, medical devices, and combination products
• integrated analytical capabilities that reduce fragmentation and handoff risk
• study designs aligned with USP <1663>, USP <1664>, ISO 10993, ICH Q3E, and related expectations
• responsive support and rapid turnaround
• a collaborative approach tailored to your product, development stage, and regulatory goals

If E&L uncertainty is slowing your program, increasing regulatory risk, or creating avoidable rework, CA Analytical Testing Services can help.

We work with clients to build practical, compliant E&L programs that support development, strengthen submissions, and accelerate the path to market.

Contact CA Analytical Testing Services today to discuss your project and build a more efficient E&L strategy.