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Daicel

Extractables & Leachables USA Sponsors and Exhibitors

The U.S. Food and Drug Administration and European Medicines Evaluation Agency (EMEA) have expressed concerns over potential toxicity and efficacy effects of chemicals released into drug products through exposure to components used in manufacturing and packaging. These chemicals are referred to as Extractables and Leachables (E&L). Accurate and definitive E&L studies should be performed in compliance with USP, ICH, PQRI, and ISO 10993. All E&L studies by Daicel Pharma Services are conducted in their US-FDA audited analytical facility and fully support regulatory compliance. Daicel Pharma Services offers GMP Analytical Services with comprehensive Extractable and Leachables Studies and GMP Stability Studies. Daicel’s Extractable and Leachables studies test a large number of packing materials, manufacturing systems, and drug products, as well as offer Glass Delamination studies to meet the demanding testing specifications of regulatory authorities. Learn more at www.daicelpharmaservices.com

Contact

  • 610-594-2100 ext: 221
  • Chiral Technologies, Inc. 800 North Five Points Road West Chester, PA 19380
  • www.daicel.com/en/