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European Biopharmaceutical Review

Managing E&L Unknown Compounds

Unknown compound characterisation has always been one of the most challenging aspects of analytical chemistry. Despite the difficulties, this identification is critical for a meaningful extractables and leachables (E&L) evaluation of container closure systems; single-use systems; drug delivery and combination products; and medical devices.

Identification of unknown extractable compounds is key to a successful E&L study due to the fact that there is no universally established concentration limit for leachable compounds. As a result, a toxicological risk assessment based on the intended dosing regimen of the product is required to determine if a potential leachable compound poses a risk to patient safety. Unfortunately, accurate and meaningful toxicological assessments are not possible for unknown compounds. These are typically assessed using a worst case scenario, where they are evaluated as extremely toxic – this however often leads to applying an inaccurate level of risk. Therefore, a systematic approach for the characterisation of unknown extractable compounds is essential to enable scientists to assign the correct degree of toxicological concern to a given analyte.

So, how does one go about identifying an unknown compound? The use of the proper instrumentation is critical. High resolution mass spectrometers that enable an accurate mass determination to at least three decimal places – such as liquid chromatographyquadrupole time of flights (LC-QTOFs) and gas chromatography (GC)-QTOFs – are suitable for this purpose and their use generates a plethora of data that can often lead to the identification of an empirical formula or class of compound for the unknown. This information can then be further evaluated with specialised software that is able to quickly search historical data and databases to provide a preliminary identification of the unknown extractable compound.

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Simone Carrara, E&L Laboratory Manager; Andrew Blakinger, Manager, Extractables & Leachables Testing; Thomas Lehman, PhD, Director, Method Development and Validation and Extractables and Leachables, Eurofins BioPharma Product Testing
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Simone Carrara
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Andrew Blakinger
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Thomas Lehman
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