Analysis of unknown (unlabeled/mislabeled) drug products for active pharmaceutical ingredients and related substances by an international mail facility satellite laboratory equipped with rapid screening devices-Reference-Cited by-同舟云学术

Analysis of unknown (unlabeled/mislabeled) drug products for active pharmaceutical ingredients and related substances by an international mail facility satellite laboratory equipped with rapid screening devices

Published:2024-05-15 Issue:4 Volume:69 Page:1212-1221
ISSN:0022-1198
Container-title:Journal of Forensic Sciences
language:en
Short-container-title:Journal of Forensic Sciences

Author:

Lanzarotta Adam¹^ORCID,Kern Sara¹,Batson JaCinta¹,Collins Melissa¹,Patel Anvi¹,Altaf Muhammad¹,Arrecis Julio¹,Boyd Brian¹,Gonzalez Illan Fernando¹,Griffin Kelsey M.¹,Howe Gregory¹,Hudson‐Davis Morgan¹,Kimani Martin¹,LaGarde Donna¹,Laguerre David¹,Loh Mark¹,Lorenz Lisa¹,Morales‐Garcia Flavia¹,Sterling Megan E.¹,Reimer Allison M.¹,Thatcher Michael¹,Wetherby Anthony E.¹

Affiliation:

1. Forensic Chemistry Center, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food and Drug Administration Cincinnati Ohio USA

Abstract

AbstractTwo chemists employed a three‐device rapid screening “toolkit” consisting of a handheld Raman spectrometer, transportable mass spectrometer, and portable Fourier transform infrared (FT‐IR) spectrometer at an international mail facility (IMF) satellite laboratory to examine unknown (unlabeled/mislabeled) products for the presence of active pharmaceutical ingredients (APIs). Phase I of this project previously demonstrated that this toolkit was the most effective collection of instruments for identifying APIs in product types collected at IMFs during a nationwide mail blitz and Phase II of this project previously demonstrated that results generated using the toolkit during a satellite laboratory pilot program were as reliable as those generated by a full‐service library when two or more of these instruments identify an API. This study (Phase III) described the results of the satellite laboratory toolkit during production mode and encompassed the period ranging from June 2021 through December 2022. During this study, a total of 858 products were examined on‐site at the IMF. The satellite laboratory yielded conclusive results for 726 (84.6%) products, which were used to support regulatory action, and identified 132 (15.4%) products that required additional full‐service laboratory analyses due to inconclusive results. The satellite and full‐service laboratory verified/confirmed at least one API/related substance in 617 (71.9%) products. A total of 709 APIs/related substances were found in the 617 products, and 202 of these 709 compounds were unique/different. Overall, during Phases I through III of this program, 350 different substances have been identified in products collected at IMFs.

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/1556-4029.15537

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