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How to Identify extractables and leachables Impurities

The packaging materials for pharmaceutical products are designed to protect them from environmental contamination. However, the presence of extractables and leachables originating from these packing materials in the pharmaceutical product can lead to a change in its composition that can in turn modify its therapeutic action, its organoleptic properties or its stability. Furthermore, the extractables and leachables can constitute a risk in themselves owing to their inherent toxicological properties, constituting a source of contamination.

The extraction studies (also called controlled extraction studies) aim to provide extensive understanding of potential leachables and extractables originating in the containers involved in the pharmaceutical development process.

To identify and quantify the extractables and leachables, the primary containers are exposed to more extreme conditions than those occurring in the usual pharmaceutical processes with the aim of determining the greatest quantity of extractables that may appear as impurities in finished product (leachables). Among the most used extraction techniques are reflux with organic solvents of different polarity, Soxhlet treatment, sonication and incubation in controlled temperature conditions, among other methods. Moreover, among the analytical techniques used for the quantitative and qualitative characterisation of this type of impurity are spectroscopic methods, such as infra-red (IR), or visible ultraviolet (UV-vis) spectroscopy, as well as chromatography, such as High performance Liquid Chromatography (HPLC) or gas chromatography (GC), both coupled with mass detectors. ICP-OES Plasma spectroscopy is also used for the quantification of metals.

The presence of extractable or leachable impurities has to be controlled to maintain the quality and stability of the pharmaceutical product, as well as consumer safety. The analytical tests on extractables and leachables, the understanding of the contaminant migration process and assessment by toxicological experts are the mechanisms for the analysis and assessment of these contaminants.

At Azierta, science and health consultancy, we have a specialist toxicology consultancy department, and we are also corporate members of EUROTOX. We have accredited toxicologists, expert in the assessment and analysis of extractables and leachables, capable of determining the inherent risk of each impurity. If you would like to know more about us, visit: Toxicological Consultancy Services.


[1] Ding, W., & Martin, J., “Implementing Single-Use Technology in Biopharmaceutical Manufacturing. BioProcess International,” 2008.

[2] Jenke, D. R., Story, J., & Lalani, R., “Extractables/Leachables from Plastic Tubing Used in Product Manufacturing. International Journal of Pharmaceutics, 315(1), 75-92.,” 2006.


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