In addition to degradation products, impurities, and exogenous contaminants, industries such as pharmaceutical, food, and others must concern themselves with leachables. These chemicals can derive from containers and closures or migrate from labels or secondary containers and packaging to make their way into products. Identification and quantification of extractables (potential leachables) and leachables, typically trace level analytes, is a regulatory expectation intended to ensure consumer safety and product fidelity. Mass spectrometry and related techniques have played a significant role in the analysis of extractables and leachables (E&L). This review provides an overview of how mass spectrometry is used for E&L studies, primarily in the context of the pharmaceutical industry. This review includes work flows, examples of how identification and quantification is done, and the importance of orthogonal data from several different detectors. E&L analyses are driven by the need for consumer safety. These studies are expected to expand in existing areas (e.g., food, textiles, toys, etc.) and into new, currently unregulated product areas. Thus, this topic is of interest to audiences beyond just the pharmaceutical and health care industries. Finally, the potential of universal detector approaches used in other areas is suggested as an opportunity to drive E&L research progress in this arguably understudied, under-published realm.

中文翻译：

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质谱法和相关技术在可萃取和可浸出化学物质分析中的作用。

除了降解产物，杂质和外来污染物外，制药，食品和其他行业也必须关注可浸出物。这些化学物质可以从容器和密闭容器中提取，也可以从标签或辅助容器和包装中迁移出来，进入产品中。对可萃取物（潜在的可浸出物）和可浸出物（通常为痕量分析物）的鉴定和量化是旨在确保消费者安全和产品保真度的监管要求。质谱法和相关技术在可萃取物和可浸出物（E＆L）的分析中发挥了重要作用。这篇综述概述了如何将质谱用于E＆L研究，主要是在制药行业中。该审核包括工作流程，如何进行识别和定量的示例，以及来自几个不同检测器的正交数据的重要性。E＆L分析受消费者安全需求的驱动。预计这些研究将扩展到现有领域（例如食品，纺织品，玩具等），并扩展到新的，目前未受管制的产品领域。因此，除了制药和保健行业之外，该主题还吸引了其他观众。最后，其他领域使用通用检测器方法的潜力被认为是一个机会，可以推动在这个可能未被充分研究，尚未充分发表的领域中的E＆L研究进展。食品，纺织品，玩具等），并进入目前未受监管的新产品领域。因此，除了制药和保健行业之外，该主题还吸引了其他观众。最后，其他领域使用通用检测器方法的潜力被认为是一个机会，可以推动在这个可能未被充分研究，尚未充分发表的领域中的E＆L研究进展。食品，纺织品，玩具等）并进入新的，目前未受监管的产品领域。因此，除了制药和保健行业之外，该主题还吸引了其他读者。最后，在其他领域，通用检测器方法的潜力被认为是一个机会，可以推动E＆L在这个尚未被充分研究，尚未发表的领域中的研究进展。