Frequently Asked Questions
10. What is a leachables study?
A leachables study is generally performed on a final drug/ENDS/e-liquid product, but may also be performed on API/BDS under certain circumstances (e.g. where disposable single use assemblies have been used in the manufacture, or where leachables data on the API/BDS container closure system is required). A leachables study is used to identify and quantify the actual levels of compounds that a patient/consumer may potentially be exposed to.
A leachables study is performed by storing representative samples of the final drug/ENDS/e-liquid product (or API/BDS as appropriate) up to the proposed shelf life, under standard chemical stability conditions (as per ICH Q1A). In fact, leachables studies can be carried out in parallel to a normal chemical stability program.
During the study, samples are pulled at regular intervals and tested for leachables using methods utilising a variety of analytical techniques. Depending on the requirements of the study, they may be developed as quantitative procedures or as limit tests. Either way, they should be validated in accordance with the guidance provided in ICH Q2(R1).
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