Leachable Studies
A leachable study directly measures how much of a compound (identified as a risk during the preceding extractable study) could potentially leach into the product over the course of its shelf life.
We offer bespoke leachable studies tailored to your unique requirements. These will be informed by your risk assessment, extractable study, and advice from a qualified toxicologist. As a first step, our expert team will develop analytical methods to accurately quantify the leachables in your product. We can also modify your existing methods, if preferred. The methods will then be validated in compliance with ICH Q2 (R2) guidelines. The final step is the leachable study, which can then be used to support your regulatory submission.
Method Development
If one or more extractable compounds are identified as potential risks during the extractable study, it becomes important to understand how much of each could leach into the product over time. In order to accurately measure this, one or more methods must be created to accurately detect them. This is accomplished in three key steps.
- Define the expected concentration range of the compound in the product.
- Develop and test a preliminary method to measure the compound.
- Challenge the method to ensure that it is accurate and ready to be finalised and validated.
Method Validation
Method validation is based on ICH Q2 (R2) guidelines and the protocol is tailored to the product and method. If the compound in question is not expected to exceed a given level, a limit test validation is the simplest solution. If the expected concentration is variable or requires accurate quantitation, a full validation is required. Once the method validation protocol is agreed, the method validation is performed and documented in the method validation report. Upon completion of the report, the leachable study can begin.
Leachable Study
Under ideal circumstances, a leachable study will measure compound leaching in real time for the duration of a product’s shelf life. However, depending on the length of the product shelf life, this may not always be practical. Alternatively, retained samples can be utilised for the leachable study, as long as they represent the entire lifecycle of the product. Upon completion of the study, our team can help you to evaluate the risks and suggest mitigation strategies.
Why choose Extractus?
We’ve been in your shoes! We have 45+ years combined experience in the pharmaceutical industry, working as E&L subject matter experts and outsourcing studies for some of the world’s largest pharmaceutical and consumer health companies. As such, we have a deep understanding of your needs, constraints, and regulatory requirements. We provide a fast, flexible, high quality, and solution-focused service to help you meet your targets on time, and within budget.