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.

中文翻译：

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探索可以减少氮氧化物的化学滤芯，氮氧化物是形成亚硝胺的常见因素


“药品中含有致癌亚硝胺”的新闻成为世界各地的头条新闻，因此监管机构要求采取风险规避措施。然而，由于亚硝胺的潜在污染原因多种多样，要完全消除亚硝胺污染并不容易。作为参与亚硝胺形成和污染的常见因素，我们专注于空气中极少量的氮氧化物，并寻找减少氮氧化物的方法。结果，我们发现化学滤芯（由 NIPPON MUKI Co.， Ltd. 制造）将氮氧化物从十亿分之几降低到几 ppb 水平。我们预计我们的发现将用作一种有用的策略，以控制原料药和药品在加工过程中反复暴露于少量氮氧化物引起的亚硝化，并导致安全可靠的药品供应。