EXTRACTABLE AND LEACHABLE IMPURITIES

Safeguard patients by controlling chemical migration from packaging and manufacturing materials.

Materials used in pharmaceutical packaging or during manufacturing can migrate into the finished product. This may alter the product’s composition, potentially affecting therapeutic efficacy, organoleptic properties, or stability, and in some cases, posing serious health risks due to toxicological properties.

ICH Q3E guideline on Extractables and Leachables (E&L)

The ICH Q3E guideline on Extractables and Leachables (E&L), just released (1 August 2025), draft under consultation until 18/12/2025, presents a holistic framework and process for the assessment and control of E&L impurities.

It also complements the existing ICH guidelines on impurities, including impurities in new drug substances (ICH Q3A) and new drug products (ICH Q3B), residual solvents (ICH Q3C), and elemental impurities (ICH Q3D), as well as DNA reactive (mutagenic) impurities (ICH M7).

Extractables and leachables: What you need to know

Extractables:

Compounds that can be released from a material under forced laboratory conditions. They represent the maximum potential exposure under extreme scenarios.

Leachables:

Compounds that actually migrate into the product under normal use and storage conditions.


We conduct complete studies of extractable substances and develop methods to monitor leachables in your final product, identifying and addressing all potential risks.

Our approach — aligned with ICH Q3E

Review of materials and processes:

We examine all materials used in packaging and production, along with procedures and equipment, to predict compatibility with your product. Each material is studied throughout the manufacturing and storage stages.

Extraction studies:

Our team designes specific studies for each material to determine behaviour under extreme conditions.

Leachable studies:

We detect volatile and semi-volatile compounds that may migrate into the final product under normal conditions.

Toxicological evaluation:

For our toxicological evaluations, we use resources from literature reviews, to read-across data, to QSAR models. This way, we define the toxicological profile of each impurity, determine safety limits, and adjust for different dosage forms.

Toxicological risk analysis:

Considering extraction data and inherent toxicology, we assess patient risk at potential exposure levels in the finished product.

Regulatory report:

Our detailed findings are documented in accordance with applicable regulations and guidelines, including FDA, EMA, PQRI, PDA –and now aligned with ICH Q3E principles.

Why work with us

We work with GMP and/or FDA-certified analytical laboratories with the capability to detect ultra-trace levels of impurities.

Our ERT-accredited toxicologists tailor studies to your product, ensuring safety and compliance with the latest regulations

Get in touch now!

For more information, please contact our Senior Toxicologist Dr. Heidi Becker.
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