Achieve Confident Extractable Testing for Medical Device Compliance
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Extractables and leachables are chemical substances that can be released from medical devices under certain conditions. Hence, testing is a critical part of the pharmaceutical development process that serves to evaluate risk and ensure compliance standards are met.
Accelerated solvent extraction (ASE) is an effective extractable profiling technique. However, the poor solubility of certain compounds can result in result in reduced recovery rates and can compromise analytical accuracy.
Download this app note to discover a new ASE system that can provide:
- Highly reproducible methods for accelerated extractables profiling
- Fully automated workflows that require minimal user intervention
- Efficient compound extraction for greater analytical accuracy
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