Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld Raman Spectrometers. Issue 4 (27th January 2020)

• Record Type: Journal Article
• Authors: Lanzarotta, Adam; Kimani, Martin M.; Thatcher, Michael D.; Lynch, John; Fulcher, Moseley; Witkowski, Mark R.; Batson, JaCinta S.
• Is Part Of: Journal of forensic sciences. Volume 65:Issue 4(2020)
• Page Start: 1274
• Page End: 1279
• Publication Date: 2020-01-27
• Subjects: forensic chemistry -- counterfeit pharmaceuticals -- controlled substances -- handheld Raman spectrometers -- authenticity testing -- TruScan; Medical jurisprudence -- Periodicals; Forensic sciences -- Periodicals; Forensic Medicine -- Periodicals; Gerechtelijke geneeskunde; Gerechtelijke chemie; Gerechtelijke psychiatrie; 363.2505
• DOI: 10.1111/1556-4029.14287
• Languages: English
• ISSNs: 0022-1198

Abstract

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.