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

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.