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ExtractablesLeachablesImpurities2014.pdf
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🔗 Source: pharmaedresources.com
📊 Size: 857 KB
📄 Pages: 8 pages
⬇️ Downloads: 154

Summary

The Extractables, Leachables, & Elemental Impurities Forum 2014 covered updates and case studies on USP <232> and <233> and ICH guidelines for elemental impurities, with presentations from industry experts, including John Kauffman from the FDA, Timothy Shelbourn from Eli Lilly, and Janeen Skutnik-Wilkinson from NSF Health Sciences. Topics included ICH Q3D guideline for metal impurities, method development and validation for elemental impurities, and determination of elemental impurities from a contract lab perspective. The forum also featured a panel discussion on whether the industry is ready for the new elemental impurities requirements. Other presentations covered extractables and leachables considerations, simulation studies, and safety assessments. The event aimed to ensure quality, safety, and regulatory compliance for drugs and biologics.

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The Extractables, Leachables, & Elemental Impurities Forum 2014 covered updates and case studies on USP <232> and <233> and ICH guidelines for elemental...

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  • File Format: PDF
  • File Size: 857 KB
  • Pages: 8
  • Language: EN
  • Total Downloads: 154
  • Last Updated: 6 hours ago

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