Pharmaceuticals and other chemical products can potentially come into contact with thousands of other chemical species in their lifetime. Container … [Read more...] about How to Avoid Regulatory Deficiencies in Extractables and Leachables Testing
We write blog posts on emerging and important aspects of analytical chemistry, focusing on lab-testing techniques.
Reducing Relative Response Factor Variation in E&L Testing
E&L testing involves investigating extractables from the product related to its materials of construction or trace impurities that may come from … [Read more...] about Reducing Relative Response Factor Variation in E&L Testing
Risk Assessment Strategies in Extractables and Leachables
Risks assessments are a key element in extractables and leachables testing. There are many factors involved in ascertaining the specific risks and how … [Read more...] about Risk Assessment Strategies in Extractables and Leachables
E&L Testing: Methods of Chemical Characterization
Extractables and leachables testing – E&L testing for short – is the process of identifying and quantifying the molecules which can be released … [Read more...] about E&L Testing: Methods of Chemical Characterization
Common Mistakes in Extractables and Leachables Analysis
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
