Exploration for Chemical Filter Cartridges that Can Reduce Nitrogen Oxides, a Common Factor in the Formation of Nitrosamines

IF 3.1 3区 化学 Q2 CHEMISTRY, APPLIED
Ryota Nomura, Takahiko Taniguchi, Kazuya Suzuoki, Rintaro Yokoi, Kanenao Akasaki, Kyoko Hirai, Osamu Uchikawa
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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.

Abstract Image

探索能减少氮氧化物的化学过滤器,氮氧化物是形成亚硝胺的常见因素
“医药产品中含有致癌性亚硝胺”的新闻成为世界各地的头条新闻,监管机构因此要求采取风险规避措施。然而,由于各种各样的潜在污染原因,完全消除亚硝胺污染并不容易。作为亚硝胺形成和污染的共同因素,我们关注空气中极少量的氮氧化物,并寻找减少它们的方法。结果,我们发现化学过滤筒(由NIPPON MUKI Co., Ltd.制造)将氮氧化物从十亿分之几十的水平降低到几ppb的水平。我们期望我们的发现将被用作一种有用的策略,以控制由原料药和药品在加工过程中反复暴露于少量氮氧化物所引起的亚硝化,并导致安全可靠的药品供应。
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来源期刊
CiteScore
6.90
自引率
14.70%
发文量
251
审稿时长
2 months
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.
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