Nitrosamines LC/MS/MS Analyser

A fully automated solution for a wide range of Nitrosamines in pharmaceutical drug substance and drug product.

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Application Notes


The inherent benefits of using a Nitrosamines Analyser and automated sample preparation for nitrosamines analysis are clear:

  • High throughput enabling greater levels of laboratory productivity
  • Unattended operation meaning researchers and analysts are free to work on more expert tasks
  • Improved data accuracy and precision for greater confidence in results
  • Minimal analyst interaction with the sample and potentially harmful chemicals for enhanced health and safety
  • Reduced risk of contamination leading to false positives and the resulting costly delays or erroneous product recalls
  • Enhanced efficiency and profitability due to optimised laboratory workflows.


Following the discovery of nitrosamines contamination in certain classes of drug products in recent years, regulators have mandated worldwide stringent reviews of the pharmaceutical industry portfolio, including challenging analytical testing to meet the recently established zero-risk environment requirements.

As a result, the Element Nitrosamines Analyser and the automated solution it provides will be of interest to pharmaceutical drug substance and drug product manufacturers to support their research, process development and quality control programs. CRO organisations offering outsourced, high throughput, testing will also benefit greatly from the quality and efficiency gains associated with this automated analysis.


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