Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld Raman Spectrometers.
TruScan
authenticity testing
controlled substances
counterfeit pharmaceuticals
forensic chemistry
handheld Raman spectrometers
Journal
Journal of forensic sciences
ISSN: 1556-4029
Titre abrégé: J Forensic Sci
Pays: United States
ID NLM: 0375370
Informations de publication
Date de publication:
Jul 2020
Jul 2020
Historique:
received:
15
11
2019
revised:
31
12
2019
accepted:
08
01
2020
pubmed:
28
1
2020
medline:
26
1
2021
entrez:
28
1
2020
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 31986222
doi: 10.1111/1556-4029.14287
doi:
Substances chimiques
Controlled Substances
0
Counterfeit Drugs
0
Tablets
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1274-1279Informations de copyright
Published 2020. This article is a U.S. Government work and is in the public domain in the USA.
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