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Identifying and Mitigating Errors in Organic Extractables & Leachables Screening

Piet Christiaens  (Scientific Director, Nelson Labs Europe)

Date: Thursday, September 10

Time: 2:00pm - 2:45pm

Pass Type: VIP Attendee, Exhibitor, Expo & Conference, Matchmaking, Student - Get your pass now!

Track: Drug Development & Delivery

Vault Recording: TBD

Organic Chromatographic “Screening” to discover, identify and quantify organic compounds in an extract or drug product is a relatively new concept to both the Pharmaceutical and Medical Device Industries. While the Chromatographic Screening process is the best solution to cover the three functions is should serve, each function of the screening process is prone to errors that are inherent to the screening methodology.
· The risk of omission: omitting a compound in chromatographic screening as fatal error
· The risk of inexact identification: mis-identifying a compound as fatal error
· The risk of inaccurate and imprecise quantitation in chromatographic screening processes.
The presentation will explain these errors in detail and how to minimize the occurrence of these errors