Extractables & Leachables

Extractables and leachables testing is an FDA required step in filings of drug products or devices to determine what effect the packaging, delivery system, device materials or any other component that interacts with the drug or patient will have on it. Additionally, drug manufacturing systems (single use systems) and components require testing to determine compounds that may leach during the manufacturing process. Results of these tests can provide useful information on how these elements impact human health through toxilogical assessments that will then determine if leachable studies need to be performed.

Extractable studies expose the device, container closure system material, or manufacturing component to stressed conditions and extract potential contaminants from the material using heat, multiple solvents and exposure time. Determination of what compounds are present after the extraction is an important step to understand if those extracted compounds pose potential toxilogical harm.

Leachable studies are designed to identify if the components identified in the extractable study will leach out of a device or container closure system and into a drug product in controlled conditions over time. Secondary packaging such as inks, labels and dyes are often a factor and need consideration in both extractable and leachable testing.

Boston Analytical extractables and leachables experts will partner with you to create studies that provide the data needed to identify risk to your drug product or medical device. Following ICH and USP guidance we’ll make certain to address all leachables that could affect your product to help you achieve FDA compliance.

Pharmaceutical Extractables and Leachables Studies

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Extractables and Leachables Studies

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