Rapid characterization of poor-quality medicines using mass spectrometry

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Donndelinger, David Vincent
Fernández, Facundo M.
Wu, Ronghu
Stockton, Amanda M.
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Communities worldwide, especially in the developing world, are afflicted with poor-quality medicines disguised as genuine medicines used for treatment of common infections. Poor-quality medicines range from expired genuine tablets to placebos containing toxins created by criminals. Numerous patients are left with untreated conditions, financial losses, and little confidence in the health system. The developing world struggles to identify and quantitate poor-quality antimalarial and antibiotic medicines. Portable devices employing robust laboratory techniques have the potential to turn the tide in this fight. Vast regions in the developing world lack laboratory analysis capabilities and therefore need portable instruments to perform medicinal quality evaluations. The portable devices lack the demonstrated capability to analyze all classes of poor-quality medicines. Results from tested devices reveal a significant gap in demonstrating the critical ability to distinguish poor-quality from genuine medicines. This study evaluated the Waters QDa mass spectrometer in identifying and quantitating common antimalarial and antibiotic medicines. This instrument correctly identified all poor-quality medicines among 7 common pharmaceutical treatments. Using a high-throughput easily customizable method, the QDa characterized all poor-quality medicines, both falsified and substandard. This capability is unparalleled among portable instruments. The QDa possesses the ability to become an instrumental asset in the fight against poor-quality medicines.
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