Our E&L studies are designed to help you identify potential foreign substances in your products, thus ensuring customer safety.
Extractables & Leachables Testing
Extractables & Leachables Assessments
Extractables & Leachables Assessments (EL Testing) are an important part of the process of ensuring the safety and efficacy of drug products. These assessments involve testing for substances that may leach out from a drug product container or packaging material, as well as substances that can be extracted from the product itself. EL testing is used to identify potential risks associated with these substances, and to ensure that they are within acceptable levels.
Why Are Extractables & Leachables Important?
Extractables and leachables are critical components of pharmaceutical product safety evaluation. They are used to assess the potential interactions between a drug product and its packaging. Extractables refer to compounds that can be extracted from a drug’s packaging, while leachables refer to compounds that can migrate from the packaging into the drug product. By understanding the presence and levels of extractables and leachables, pharmaceutical companies can ensure their products are safe for use by consumers.
When Should You Perform an Extractable & Leachables Assessment?
In drug packaging development, it is essential to perform an E&L (Extractables and Leachables) assessment at the appropriate time. This assessment helps to identify any potential risks associated with the extractable compounds that may be present in the packaging materials and any leachable compounds that may migrate into the drug product. The best time to perform an E&L analysis is during the early stages of the drug packaging development lifecycle process, before manufacturing and clinical trials begin. This will ensure that any potential risks are identified and addressed before they could cause harm to patients or affect product performance.
Averica: Solutions tailored to your specific project needs
Our E&L services allow us to identify a wide range of potential contaminants in your product, such as chemicals, solvents, and metals, as well as their effects on the product’s performance. With our comprehensive E&L studies, we can provide you with detailed reports that will help you make informed decisions about the safety of your products.
Unmatched quality and accuracy
Our team of experts utilizes the best practices and state-of-the-art technology to provide you with an unmatched accuracy in results. We can help you identify leachables from early-stage Investigational New Drug applications to New Drug Applications, quickly and efficiently.
Ad-hoc Research Services
We offer specialized ad-hoc research services based on our E&L studies, such as client/patient complaints, product appearance changes, unknown peaks through a stability study, as well as unknown leachables.
Flexible Solutions for your Specific project needs
Our team will work closely with you to provide the best solution for you.
Find out more about Averica E&L Testing
Contact us today to learn more about our extractables and leachables testing services.