A Non-targeted Approach to Nitrosamine Screening down to PPB Levels

Ellutia, a leading provider of innovative analytical solutions, has recently launched the Automated Total Nitrosamine Analyser, a cutting-edge system that allows pharmaceutical companies and their suppliers to rapidly screen samples for total nitrosamine content down to ppb levels. The system is designed to supplement targeted nitrosamine testing, offering a faster and more comprehensive approach to identifying potential contaminants in pharmaceutical drugs.

The need for this technology stems from the discovery of NDMA in Sartans in 2018, which led to increased concerns over nitrosamines in pharmaceutical drugs. Nitrosamines are potent carcinogens that can be formed unintentionally during the chemical synthesis of active pharmaceutical ingredients (APIs). As time has progressed, the focus has shifted to other Nitrosamine drug substance-related impurities (NDSRIs), which are often more complex and difficult to detect.

Targeted nitrosamine testing, which involves testing for specific nitrosamines, has been the most common analysis method to date. However, this approach only detects what the tester is looking for and is limited to known nitrosamines for which standards are available. The Automated Total Nitrosamine Analyser overcomes these limitations by screening for total nitrosamine content, including unexpected nitrosamines for which standards may not exist.

The system offers a rapid and comprehensive approach to screening samples for nitrosamine content, allowing pharmaceutical companies to identify potential contaminants much more quicker. This enables them to focus their efforts using targeted analysis only on positive samples and avoid unexpected nitrosamine contamination from incoming ingredients.

For more information about the Ellutia Automated Total Nitrosamine Analyser, please visit the following link.