Rapid detection of active pharmaceutical ingredients in drug products collected at an international mail facility by a satellite laboratory using a “toolkit” consisting of a handheld Raman spectrometer, portable mass spectrometer and portable FT-IR spectrometer

Lanzarotta, Adam; Kern, Sara E.; Batson, JaCinta S.; Boyd, Brian; Kimani, Martin M.; Kuo, Weiwei; Lagarde, Donna; Loh, Mark; London, Laurenee; Lorenz, Lisa; Melendez, Rebeca; Morales-Garcia, Flavia; Thatcher, Michael D.; Wetherby, Anthony E.; Witkowski, Mark

doi:10.1016/j.jpba.2022.115153

Cited by 5 publications

(2 citation statements)

References 9 publications

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“…[30][31][32][33][34][35][36][37] Using the toolkit, rapid screening techniques have been developed and are actively being used at IMFs and ports of entry by FDA chemists. [38][39][40] These techniques are quick, easy, and ideal for screening products under FDA purview at remote sampling locations for the presence of a wide range of drug products, including nitazene compounds.…”

Section: Introductionmentioning

confidence: 99%

“…The FCC has employed a toolkit consisting of a handheld Raman spectrometer (including via SERS), portable FT‐IR spectrometer, and DART‐TD‐MS instrument to examine FDA‐regulated products for the presence of active pharmaceutical ingredients (APIs) 30–37 . Using the toolkit, rapid screening techniques have been developed and are actively being used at IMFs and ports of entry by FDA chemists 38–40 . These techniques are quick, easy, and ideal for screening products under FDA purview at remote sampling locations for the presence of a wide range of drug products, including nitazene compounds.…”

Section: Introductionmentioning

confidence: 99%

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Rapid screening of 2‐benzylbenzimidazole nitazene analogs in suspect counterfeit tablets using Raman, SERS, DART‐TD‐MS, and FT‐IR

Kimani

Kern

Lanzarotta

et al. 2023

Drug Testing and Analysis

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Developing methods to rapidly screen for novel synthetic 2-benzylbenzimidazole opioids, also known as nitazenes, has become increasingly important due to their high potency. These compounds have potency comparable or exceeding that of fentanyl by up to 10 times and have been implicated in approximately 5% of all drug overdose deaths in the United States in 2021. This paper details the authenticity determination of suspect tablets and the identification of three nitazene analogs (N-pyrrolidino etonitazene, isotonitazene, and etodesnitazene) in suspect tablets seized at a mail facility using Raman and surface-enhanced Raman scattering (SERS) with handheld devices, portable Fourier transform infrared spectrometer (FT-IR), and a direct analysis in realtime ambient ionization coupled to a thermal desorption unit and a mass spectrometer (DART-TD-MS). These methods are rapid and excellent for screening opioids in suspect tablets but could not fully determine the exact structure of some of the nitazene analogs present due to spectral similarities or similar fragmentation patterns.Liquid chromatography-mass spectrometry (LC-MS) confirmed the presence of these nitazene compounds in addition to other opioids/drugs that were in trace quantities. The quantitative high-performance liquid chromatography coupled with ultraviolet (HPLC-UV) detection experiments determined that the suspect tablets contained an average of 0.817 mg of N-pyrrolidino etonitazene per tablet. The results obtained reveal that the simultaneous deployment of these complementary and orthogonal portable analytical techniques as part of a workflow allows suspect tablets to be screened and nitazene-type drugs to be identified in suspect counterfeit tablets at remote sampling sites.

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