Impurities in drug substances (DS) and drug products (DP) must be continuously controlled and monitored in order to safeguard the quality and safety for the patient.
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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

How mass spectrometry can give you very good ID’s

Published Date: June 2, 2022

Impurities in drug substances (DS) and drug products (DP) must be continuously controlled and monitored in order to safeguard the quality and safety of the patient. Reporting, identification, and qualification thresholds for impurities and setting acceptance criteria are available in regulatory guidance. When during routine quality control a new or previously unidentified impurity suddenly emerges above the identification or qualification threshold, the impurity needs to be identified, often under time pressure. One of the common analytical strategies and unquestionably a powerful tool for the identification of impurities is high-resolution accurate mass spectrometry (HRAM MS) in combination with tandem mass spectrometry (MS/MS) for structural elucidation. However, not all compounds that are responsive to LC/UV are equally responsive to LC/MS, especially in the case of leachable impurities. Hence the analytical toolbox for impurity identification should not be limited to LC/MS alone.

In this presentation, this will be demonstrated with case studies where unexpected impurities in drug products were eventually identified as leachables using an expanded mass spectrometry toolbox.

Learn about the presenter below.

Ward D’Autry

study director structural elucidation at Nelson Labs

Ward D’Autry is study director structural elucidation at Nelson Labs, where he manages projects related to the identification of unknowns using high-end mass spectrometry platforms. Mr. D’Autry received his Ph.D. from the Laboratory for Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences of the University of Leuven (Belgium) in 2010. From 2010 to 2017 he worked for DSM and SABIC in Geleen, The Netherlands, where he worked as R&D scientist developing and optimizing chromatography & mass spectrometry based analytical methods for improved analysis of (complex) petrochemical samples or polymeric systems. Often the work included de novo interpretation of mass spectral data. From 2017 onwards, Mr. D’Autry works for Nelson Labs Europe as study director extractables & leachables. Until recently, he managed extractables & leachables studies with focus on manufacturing components. In 2021 he transitioned to his current role as study director structural elucidation.

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