Extractable and leachable (E&L) testing quantifies the risks associated with finished pharmaceutical product containers, bioprocess manufacturing systems, and medical devices. Extractable and leachables studies are designed to be optimized and customized for the pharmaceutical container or closure under investigation, such as materials and their compatibility with extraction solvents, type of container, type of contact between the container and the medicinal product, storage conditions, specific administration or reconstitution procedures, type of medicinal product, route of administration, dosing regimen, and associated threshold requirements. Identification and quantification of potentially harmful leachable impurities is critical as these could migrate from pharmaceutical container closure systems to contaminate a pharmaceutical product and so pose a risk to a patient’s health and cause significant quality issues.

Our team at VitelyBio is specialised in analytical assessment for Extractable and leachables & can identify potential sources of risk through strategic screening studies.

Our experts can provide consultative support at every stage of the Extractable and leachables process, from understanding Extractable and leachables regulatory requirements to deciding on a suitable test strategy to decoding the results.

Applicable Standards





Analytical Expertise

Headspace coupled to gas chromatography with mass spectral detection (HS-GC/MS)

Gas chromatography with a mass spectral detection (GC/MS)

Liquid chromatography with a diode array detection combined with mass spectral detection (HPLC-UV/MS)

Liquid chromatography with multiple order mass spectral detection (LC/MS/MS)

UV/VIS – Spectrophotometry

Infrared spectrophotometry (FTIR)