Extractables and leachables (E&L) testing is essential for understanding whether compounds originating from packaging, delivery devices, single-use systems, tubing, filters, seals, or other process-contact materials can migrate into a drug product and affect its quality, stability, or usability. For pharmaceutical and biotech developers, E&L work is not simply an analytical exercise—it is a decision-making tool that supports material selection, formulation compatibility assessment, process understanding, and long-term product robustness. BOC Sciences provides comprehensive Extractables and Leachables Testing services for small molecules, biologics, peptides, oligonucleotides, injectables, inhalation products, ophthalmics, and combination-product-related materials. Our scientists design study conditions based on product type, material composition, route of administration, and real-use contact scenarios, then integrate orthogonal analytical workflows to identify unknowns, quantify target compounds, and generate practical data packages that help teams move forward with confidence.
We develop scientifically justified extraction strategies for packaging components, elastomers, polymer films, single-use assemblies, and other process-contact materials, supported by our analytical platform for broad chemical characterization.
Our team performs targeted and non-targeted leachables investigations in formulated products under simulated or real-use conditions, supported by robust method development, validation and transfer strategies when higher selectivity or sensitivity is required.
Unknown peaks are often what delay projects. We combine high-information workflows from our analytical technologies portfolio with library search, fragmentation interpretation, and material knowledge to accelerate identification.
When teams are selecting between packaging systems, elastomer formulations, films, or tubing assemblies, BOC Sciences generates comparative datasets to support evidence-based decisions, often in combination with analytical development and quality control planning.
BOC Sciences helps sponsors identify chemical migrants early, understand material-product interactions, and build stronger analytical evidence for packaging and process decisions.
We apply dedicated GC-MS testing workflows to detect and characterize volatile and semi-volatile compounds such as residual monomers, antioxidants, plasticizers, solvents, and low-molecular-weight degradants released from packaging and polymer-based components.
Our LC-MS testing capabilities support the investigation of nonvolatile and polar compounds, including oligomers, additives, surfactant-related species, and formulation-interacting impurities that are often missed by gas-phase methods alone.
For inorganic and ionic risk assessment, we integrate ICP-MS and ion-based workflows to evaluate elemental impurities, catalyst residues, inorganic extractables, and ionic migrants that may originate from pigments, fillers, stabilizers, or processing aids.
Depending on analyte class and matrix complexity, we select headspace, direct injection, liquid-liquid extraction, solid-phase extraction, or concentration workflows to improve recovery, reduce interference, and expand detectable compound coverage.
E&L profiles are strongly influenced by material composition and thermal history. We support interpretation with thermal analysis to better understand polymer behavior, degradation tendencies, and stress-related changes that may affect extractables release.
Complex E&L samples require selective separation before meaningful identification can occur. Our chromatography testing workflows are tailored to isolate overlapping signals, improve peak resolution, and support reliable data interpretation.
We support E&L projects across pharmaceutical development programs involving packaging materials, delivery systems, manufacturing contact surfaces, and formulated products. Our study design is customized to the chemistry, dosage form, and intended contact scenario of each project.
Share your formulation type, contact materials, and development question. Our team will design a targeted extractables and leachables strategy aligned with your actual product risk points.
We begin by reviewing your dosage form, material set, route of administration, formulation characteristics, and contact conditions. This step defines high-priority components, likely migrant classes, and the most informative analytical path for your project.
Our scientists select extraction conditions, sample preparation workflows, screening methods, and confirmation techniques according to matrix complexity and expected chemistry. We establish a balanced plan for broad detection while preserving interpretability.
We perform multi-technique analysis, align signals across platforms, investigate unknown peaks, and compare findings against material knowledge and likely source hypotheses. Quantitative follow-up is incorporated where compounds require closer evaluation.
Final deliverables include a clear analytical summary, compound tables, identification rationale, comparative interpretation, and practical recommendations for next-step studies, material selection, or additional product-specific monitoring.
Low-abundance unknowns can be difficult to identify, especially when matrix interference, oligomer clusters, or co-eluting additives obscure the signal. BOC Sciences addresses this challenge through selective sample preparation, orthogonal separation design, accurate-mass interpretation, and multi-platform data correlation to improve structural confidence and reduce ambiguous results.
Biologics, lipid-containing systems, high-salt buffers, and surfactant-rich formulations can suppress analyte response and complicate recovery. We design matrix-aware methods that minimize analytical interference while preserving sensitivity for relevant migrant classes, enabling more reliable detection in real product environments.
Single-use assemblies can contain multiple polymer films, connectors, adhesives, and processing aids, creating a broad and sometimes variable extractables profile. Our workflows break the system into risk-prioritized elements, compare component-level contributions, and help clients identify the most informative test hierarchy before larger studies are launched.
Early packaging choices often need to be made before long-term product history is available. We generate comparative E&L datasets for alternative stopper, syringe, bag, tubing, or film systems so teams can rank options based on chemical cleanliness, formulation compatibility, and overall development practicality.
Partner with BOC Sciences to investigate chemical migrants from packaging and process-contact materials before they become costly development obstacles. Our E&L team combines analytical depth with practical interpretation tailored to pharmaceutical decision-making.
We do not apply generic extraction templates. Each E&L program is built around your product type, materials, contact conditions, and analytical decision points, helping you generate data that are both defensible and useful.
Our workflows are structured to capture volatile, semi-volatile, nonvolatile, ionic, and elemental species so that chemically diverse migrants are less likely to be overlooked during early screening or product-specific follow-up.
Unknown compound investigation is one of the most demanding parts of E&L analysis. BOC Sciences emphasizes cross-platform confirmation, fragmentation logic, and source-oriented interpretation to improve identification confidence.
We translate analytical findings into practical conclusions for formulation, packaging, and process teams. That means clearer comparison between materials, better prioritization of follow-up work, and easier internal decision-making.
Client Needs: A drug developer working on a peptide injection needed to compare two elastomer stopper configurations for a phosphate-buffered formulation containing a nonionic surfactant. The team wanted to understand which closure system presented lower migration risk before final package selection.
Challenges: The formulation matrix created broad background signals, and the suspected migrants included both volatile antioxidants and nonvolatile oligomeric species. The client also needed a practical comparison rather than a purely descriptive compound list.
Solution: BOC Sciences designed a controlled extractables study followed by matrix-aware targeted and non-targeted leachables assessment. We applied GC-MS, LC-MS, and elemental screening, then aligned compound classes to likely elastomer additives and processing residues. Comparative interpretation focused on total profile complexity, repeated markers, and formulation-specific relevance.
Outcome: The client received a clear side-by-side assessment showing one closure system had a simpler migration profile and fewer repeat high-interest markers, supporting a more confident packaging decision for the peptide product.
Client Needs: A biologics process team needed extractables characterization for a multilayer single-use bag and associated tubing assembly used during a neutral-pH monoclonal antibody hold step. Their concern centered on polymer-related migrants under process-relevant contact conditions.
Challenges: The assembly contained multiple contact materials, making it difficult to determine whether the dominant signals originated from the film, tubing, or connector subcomponents. Several detected compounds were present at very low abundance and required careful interpretation.
Solution: We created a tiered study plan that combined whole-assembly extraction with component-level follow-up to localize likely source materials. Orthogonal screening was used to capture volatile, semi-volatile, and nonvolatile species, while thermal and material-behavior context supported interpretation of polymer-derived compounds and additive breakdown products.
Outcome: BOC Sciences identified the primary contribution pattern across the assembly and highlighted which contact materials warranted closer control, enabling the client to refine material selection and reduce uncertainty in the hold-step strategy.
Client Needs: A sponsor developing an inhalation suspension requested an investigation into potential migrants from a device-contact polymer component and sealing material. Their formulation contained a poorly water-soluble active and a volatile co-solvent, increasing concern around compound extraction and long-term interaction.
Challenges: The inhalation matrix complicated recovery of low-level organic species, while expected migrants spanned both volatile and semivolatile ranges. The client needed evidence connecting the observed profile to likely material origin, not just instrument output.
Solution: BOC Sciences applied headspace and solvent-based analytical workflows in parallel, then used chromatographic optimization and accurate-mass interpretation to distinguish formulation-derived signals from component-derived signals. We also compared the profile against reference extracts from isolated device materials to strengthen source attribution.
Outcome: The study clarified which signals were formulation-related and which were linked to the contact materials, allowing the client to prioritize component refinement and move forward with a more focused development plan.
Extractables are chemical compounds that can be released from packaging, processing, or delivery-contact materials under intentionally challenging laboratory conditions, while leachables are compounds that actually migrate into a drug product during normal contact conditions. This distinction matters because extractables help predict potential risks early, and leachables help confirm what may be present in the final product environment. BOC Sciences supports drug developers with tailored E&L study design, material screening, compound identification, and analytical interpretation for informed formulation and packaging decisions.
Extractables and leachables testing is important because chemicals may migrate from container closures, manufacturing components, tubing, filters, elastomers, adhesives, or delivery systems into drug products, potentially affecting product quality and development confidence. For drug developers, E&L testing provides a scientific basis for selecting materials, comparing suppliers, understanding compatibility, and reducing late-stage uncertainty. BOC Sciences helps clients evaluate these risks using analytical workflows designed around the product type, contact materials, and intended development strategy.
E&L studies are most useful when they begin early enough to support material, packaging, and process-equipment decisions before a formulation or container system becomes difficult to change. Extractables studies can guide initial selection by revealing potential chemical migrants, while leachables studies can later focus on compounds that may actually appear under representative product-contact conditions. BOC Sciences can help developers plan phased testing strategies that align with formulation evolution, packaging selection, and risk-based decision making without overtesting too early.
Common E&L testing samples include container closure components, vials, stoppers, syringes, cartridges, bags, tubing, filters, single-use systems, processing aids, and other materials that may contact the formulation during manufacture, storage, or delivery. The right sample set depends on the product format, contact duration, material composition, and whether the study is exploratory or confirmatory. BOC Sciences works with drug development teams to define representative samples and extraction conditions so the resulting data are meaningful for real-world product-contact scenarios.
Extractables and leachables are typically investigated using complementary analytical techniques because potential migrants may include volatile, semi-volatile, non-volatile, organic, inorganic, or elemental species. Screening often combines separation, detection, and structural elucidation approaches to build a chemical profile, then targeted methods may be used for compounds of interest. The goal is not only to detect signals, but to understand what they are, where they may come from, and whether they are relevant to product development decisions.
We had data from several labs, but BOC Sciences was the first team to truly explain what the unknowns likely were and why they mattered for our packaging decision. Their interpretation was every bit as valuable as the instrument work.
— Dr. Morgan T., Director of Pharmaceutical Development
The project involved multiple films, connectors, and tubing materials, and the risk picture was not obvious. BOC Sciences built a smart study hierarchy and helped us understand where the most meaningful extractables signals were actually coming from.
— Elena R., Upstream Process Scientist
Instead of overwhelming us with raw chemistry, the team gave us a clear comparison between candidate closure systems and highlighted the differences that mattered for our formulation. That made internal decision-making much easier.
— James W., CMC Project Manager
Our biggest bottleneck was a cluster of unresolved unknown peaks. BOC Sciences used multiple techniques to narrow the structures and connect them to likely material sources, which gave our team a much stronger scientific basis for next steps.
— Dr. Patel, Senior Analytical Lead
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