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Jon Bardsley

As seen in: NewsBreak, BioPharm International, Pharmaceutical Outsourcing
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Articles

Advantage of Orbitrap Technology for NDSRI Quantitation: An N-Nitroso Duloxetine Case Study 

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By Jon Bardsley, George Stez
| Thermo Fisher
In October 2024, thousands of bottles of the popular antidepressant Duloxetine were recalled due to the presence of N-Nitroso Duloxetine1, a nitrosamine drug substance-related impurity (NDSRI). This issue has continued to pose significant challenges for pharmaceutical manufacturers since nitrosamine impurities were first highlighted in 2018.
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Metabolite Identification Solutions showcased at Great Lakes DMDG 2024 Meeting

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By Jon Bardsley
| Thermo Fisher
It’s never easy to catch all the great science presented at different conferences these days – so in case you can’t make it, and if MetID is your area of interest, you can now learn about and download the great posters being presented at the Great Lakes DMDG 2024 meeting held at Purdue University in May below.
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Tools and Technologies for Robust Method Lifecycle Management in Liquid Chromatography

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By Jon Bardsley
| NewsBreak
FDA Grants Accelerated Approval for Eisai Alzheimer’s Disease Treatment Eisai’s Alzheimer’s treatment, Leqembi (lecanemab-irmb), received approval from FDA via the Accelerated Approval pathway. FDA announced the approval of Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease on Jan. 6, 2023.
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