Citation

Lanzarotta A, Kimani MM, Thatcher MD, Lynch J, Fulcher M, Witkowski MR, Batson JS. J. Forensic Sci. 2020; ePub(ePub): ePub.

Affiliation

Forensic Chemistry Center, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food & Drug Administration, Cincinnati, OH, 45237.

Copyright

(Copyright © 2020, American Society for Testing and Materials, Publisher John Wiley and Sons)

DOI

10.1111/1556-4029.14287

PMID

31986222

Abstract

This study describes the performance of handheld Raman devices for determining whether suspect pharmaceutical tablets declared to contain controlled substances were consistent with authentic (CWA) or not consistent with authentic (NCWA) tablets using a simple, rapid, field-friendly method capable of being used by nonexperts. Twenty-five authentic products and 84 known NCWA tablets were examined using three "parent" devices for a total of 327 analyses. On average, the parent devices yielded a true pass rate of 100%, a true fail rate of 98.4%, a false pass rate of 1.6%, and a false fail rate of 0%. The methods/libraries were then transferred to 13 identical "daughter" devices, which were used to examine 10 suspect finished dosage forms in duplicate (six known NCWA tablets and four authentic tablets) for a total of 260 measurements. On average, the daughter devices had a true pass rate of 100%, a true fail rate of 95.5%, a false pass rate of 4.5%, and a false fail rate of 0.0%. These data demonstrate that the parent-daughter electronic transfer method was successful, which permits the ability to develop methods in the laboratory that can be seamlessly pushed out to field devices. The methods can then be used to (i) prioritize samples for additional testing using other more time-consuming laboratory-based techniques needed to detect and quantify active ingredients and (ii) help support the interdiction of dangerous tablets at ports of entry, thereby preventing them from reaching the supply chain.

Published 2020. This article is a U.S. Government work and is in the public domain in the USA.

Language: en

Keywords

TruScan; authenticity testing; controlled substances; counterfeit pharmaceuticals; forensic chemistry; handheld Raman spectrometers