{"title":"Exploration for Chemical Filter Cartridges that Can Reduce Nitrogen Oxides, a Common Factor in the Formation of Nitrosamines","authors":"Ryota Nomura, Takahiko Taniguchi, Kazuya Suzuoki, Rintaro Yokoi, Kanenao Akasaki, Kyoko Hirai, Osamu Uchikawa","doi":"10.1021/acs.oprd.4c00301","DOIUrl":null,"url":null,"abstract":"News of “carcinogenic nitrosamines contained in pharmaceutical products” have made headlines around the world, and risk avoidance measures have been demanded by regulatory bodies as a consequence. However, it is not easy to completely eliminate contamination with nitrosamines because of a wide variety of potential causes of contamination. As a common factor involved in the formation and contamination of nitrosamines, we focused on the extremely small amount of nitrogen oxides in the air and searched for ways to reduce them. As a result, we found that the chemical filter cartridges (made by NIPPON MUKI Co., Ltd.) decreased nitrogen oxides from the tens of parts per billion level to the several ppb levels. We expect that our finding will be used as one useful strategy to control the nitrosation caused by repeated exposure of the drug substances and drug products to small amounts of nitrogen oxides during processing and lead to the supply of safe and reliable pharmaceutical products.","PeriodicalId":55,"journal":{"name":"Organic Process Research & Development","volume":"29 1","pages":""},"PeriodicalIF":3.1000,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Organic Process Research & Development","FirstCategoryId":"92","ListUrlMain":"https://doi.org/10.1021/acs.oprd.4c00301","RegionNum":3,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CHEMISTRY, APPLIED","Score":null,"Total":0}
引用次数: 0
Abstract
News of “carcinogenic nitrosamines contained in pharmaceutical products” have made headlines around the world, and risk avoidance measures have been demanded by regulatory bodies as a consequence. However, it is not easy to completely eliminate contamination with nitrosamines because of a wide variety of potential causes of contamination. As a common factor involved in the formation and contamination of nitrosamines, we focused on the extremely small amount of nitrogen oxides in the air and searched for ways to reduce them. As a result, we found that the chemical filter cartridges (made by NIPPON MUKI Co., Ltd.) decreased nitrogen oxides from the tens of parts per billion level to the several ppb levels. We expect that our finding will be used as one useful strategy to control the nitrosation caused by repeated exposure of the drug substances and drug products to small amounts of nitrogen oxides during processing and lead to the supply of safe and reliable pharmaceutical products.
期刊介绍:
The journal Organic Process Research & Development serves as a communication tool between industrial chemists and chemists working in universities and research institutes. As such, it reports original work from the broad field of industrial process chemistry but also presents academic results that are relevant, or potentially relevant, to industrial applications. Process chemistry is the science that enables the safe, environmentally benign and ultimately economical manufacturing of organic compounds that are required in larger amounts to help address the needs of society. Consequently, the Journal encompasses every aspect of organic chemistry, including all aspects of catalysis, synthetic methodology development and synthetic strategy exploration, but also includes aspects from analytical and solid-state chemistry and chemical engineering, such as work-up tools,process safety, or flow-chemistry. The goal of development and optimization of chemical reactions and processes is their transfer to a larger scale; original work describing such studies and the actual implementation on scale is highly relevant to the journal. However, studies on new developments from either industry, research institutes or academia that have not yet been demonstrated on scale, but where an industrial utility can be expected and where the study has addressed important prerequisites for a scale-up and has given confidence into the reliability and practicality of the chemistry, also serve the mission of OPR&D as a communication tool between the different contributors to the field.