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Extractables and Leachables (E&L) from pharmaceutical packaging, medical devices, and process equipment can potentially pose risks to the safety, efficacy, and stability of pharmaceutical or medical products. As part of safety risk assessment, it is very important to confidently identify those E&L compounds. However, the confident identification of extractables and leachables can be challenging due to the diverse chemical structures and properties of polymer additives found in the manufacturing and packaging components, and medical devices.
Join our webinar to explore the levels of identification confidence illustrated in USP <1663> and strategies to achieve confident identification.
Agenda:
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Extractable and Leachables (E&L) identification (ID) category per USP <1663>
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Approaches to achieve more confident ID by LC/MS and GC/MS
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A case study to investigate a leachable from secondary packaging by GC-HRMS
This free webinar is aimed at:
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Managers, scientists, engineers who are involving in the extractables and leachables field
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Analytical chemists who are interested in new techniques in terms of confident organic compound identification
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Anyone who are interested in subcontracting E&L testing
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E&L Testing Solutions
Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.
Discover our services and how we can help.
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