Evaluation of "Toolkit" consisting of handheld and portable analytical devices for detecting active pharmaceutical ingredients in drug products collected during a simultaneous nation-wide mail blitz

被引：12

作者：

Lanzarotta, Adam ^{[1
]}

Kern, Sara ^{[1
]}

Batson, JaCinta ^{[1
]}

Falconer, Travis M. ^{[1
]}

Fulcher, Moseley ^{[1
]}

Gaston, Kirk W. ^{[1
]}

Kimani, Martin M. ^{[1
]}

Lorenz, Lisa ^{[1
]}

Morales-Garcia, Flavia ^{[1
]}

Ranieri, Nicola ^{[1
]}

Skelton, David ^{[1
]}

Thatcher, Michael D. ^{[1
]}

Toomey, Valerie M. ^{[1
]}

Voelker, Sarah ^{[1
]}

Witkowski, Mark R. ^{[1
]}

机构：

[1] US FDA, Forens Chem Ctr, Off Regulatory Sci, Off Regulatory Affairs, Cincinnati, OH 45237 USA

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2021年 / 203卷

关键词：

Handheld; Portable; Raman; FT-IR; MS; Drugs; FDA;

D O I：

10.1016/j.jpba.2021.114183

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

A "toolkit" consisting of a handheld Raman spectrometer equipped with a 1064 nm laser, a portable Fourier transform infrared (FT-IR) spectrometer and a portable direct analysis in real-time mass spec-trometer (DART-MS) was employed in a laboratory setting to examine 82 representative products collected during a nationwide mail blitz for the presence of APIs. These results were compared to those obtained using laboratory-based methods; 8 of the products were not found to contain APIs and 74 of the products were found to contain a total of 88 APIs (65 of the 88 APIs were unique). The individual performance of each device and combined performance of the three-device toolkit were evaluated with regard to true positives, true negatives, false positives and false negatives. Using this toolkit, 81 (92.0 %) of the APIs were detected by at least one technique and 47 (64.8 %) of the APIs were detected by at least two techniques. Seven false negatives (8.0 %) were encountered and while the toolkit yielded 12 false positives, no false positives were detected by more than one technique. Overall, this study demon-strated that when the toolkit detects an API using two or more devices, the results are as reliable as those generated by a full-service laboratory. Published by Elsevier B.V.

引用

页数：9

共 1 条

[1] 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
Batson, JaCinta
Boyd, Brian
Kimani, Martin M.
Kuo, Weiwei
LaGarde, Donna
Loh, Mark
Adeoshun, Laurenee L.
Lorenz, Lisa
Melendez, Rebeca
Morales-Garcia, Flavia
Thatcher, Michael
Wetherby Jr, Anthony E.
Witkowski, Mark R.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2023, 224

← 1 →