Abstract：
Two 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.
摘要：
两名化学家采用了由手持式拉曼光谱仪组成的三设备快速筛查“工具包”，可移动质谱仪，和便携式傅立叶变换红外（FT-IR）光谱仪在国际邮件设施（IMF）卫星实验室检查未知（未标记/错误标记）产品的活性药物成分（API）的存在。该项目的第一阶段先前证明，该工具包是在全国范围内的邮件突击行动中在IMF收集的产品类型中识别API的最有效工具集合，而该项目的第二阶段先前证明，在卫星实验室试验计划中使用该工具包产生的结果与当两个或多个这些工具识别API时由全方位服务库产生的结果一样可靠。这项研究（第三阶段）描述了卫星实验室工具包在生产模式下的结果，涵盖了2021年6月至2022年12月的时期。在这项研究中,共有858种产品在国际货币基金组织进行了现场检查。卫星实验室对726种(84.6%)产品得出了结论性结果,用于支持监管行动，并确定了132种（15.4%）产品，由于结果不确定，需要额外的全方位服务实验室分析。卫星和全方位服务实验室在617种（71.9％）产品中验证/确认了至少一种API/相关物质。共在617种产品中发现709种原料药/相关物质，这709种化合物中的202种是独特的/不同的。总的来说,在该计划的第一阶段至第三阶段，在IMFs收集的产品中已鉴定出350种不同的物质。
