The first detection of nitrosamines in valsartan preparations took place two years ago. Since then, it has become obvious that the problem of contamination of pharmaceutical products with nitrosamines is of greater consequence than initially assumed.
In our follow-up publication in the renowned Journal of Pharmaceutical and Biomedical Analysis, we focus on the development of suitable and universal analytical methods for a safe, flexible and wide-ranging detection of nitrosamines. The SFC-MS/MS method we developed achieves a separation of sixteen nitrosamines with a total run time of only 11.5 min.
In addition, our ‘vital’ method offers a high degree of adaptability, which ensures that the continuously changing regulatory requirements can be implemented within the shortest possible time. The aim, in addition to our contribution to the ongoing risk assessment of the pharmaceutical industry and regulatory authorities, is to develop an understanding of the causes of nitrosamine formation, secure the supply of medicines and prevent drug shortages.
The complete publication can be found here: *click*