An important step in determining the biological compatibility and safety of a medical device as required by ISO 10993 is chemical characterization. … [Read more...] about Common Mistakes in Extractables and Leachables Analysis
We write blog posts on emerging and important aspects of analytical chemistry, focusing on lab-testing techniques.
How to Measure Extractables and Leachables
Extractables and leachables are compounds that can be extracted from a product either in the presence of a solvent or simply over time through direct … [Read more...] about How to Measure Extractables and Leachables
Overcoming Uncertainty in E&L Testing
E&L testing is carried out on plastic products to understand which molecules, such as antioxidants, slip agents, surfactants lubricants, etc. are … [Read more...] about Overcoming Uncertainty in E&L Testing
What Extractable and Leachable Compounds are Found in Syringes?
Extractables and leachables are chemicals that can be extracted from a product such as a syringe and deposited into the product it is housing. This … [Read more...] about What Extractable and Leachable Compounds are Found in Syringes?
What are Extractables and Leachables?
Container systems for drug products should not release any chemicals which can build up in quantities that could create a risk of toxicity or impact … [Read more...] about What are Extractables and Leachables?
