Trace Analytical Methods and Techniques for Testing Extractables and Leachables
Trace level analysis plays a critical role in the pharmaceutical industry, especially since it is a requirement to work at trace level for multiple types of testing, such as testing for extractables and leachables (E&L), in order to identify harmful compounds present. It can be difficult to navigate this type of testing because of the varying definitions of “trace level” in each industry, also making analytical method validation a challenging task.
This white paper will:
- Provide an overview of trace level and its impact on different industries
- Examine issues related to trace level testing
- Offer solutions for trace method analysis
- Review a case study that compares different analytical methods for analyzing a rubber stopper.
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