Leachables Method Development And Validation And The Updated Relevant ICH References

By Will Parker

The final stage in assessing drug packaging involves identifying the actual leachables present in the drug throughout its shelf life. This is typically achieved through a leachables stability study, which includes both accelerated and normal storage conditions. Results from the accelerated conditions are often used to support regulatory submissions. However, before these studies can commence, it's crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.