Merieux NutriSciences approach | Nitrosamine alert

Mérieux NutriSciences' approach to addressing the global nitrosamine alert incorporates several innovative elements that significantly advance current solutions on the market, with promising implications for future developments in the pharmaceutical industry.

Innovative aspects of our approach.

Advanced Mass Spectrometry Technologies: Mérieux NutriSciences has integrated cutting-edge mass spectrometry techniques, specifically high-resolution mass spectrometry, into its nitrosamine detection methodologies. This technology enables the identification and quantification of nitrosamines at exceptionally low levels, far surpassing the capabilities of traditional detection methods. High-resolution mass spectrometry provides a more comprehensive analysis by distinguishing nitrosamines from other similar compounds, enhancing both specificity and sensitivity.Holistic Analytical Strategies: Unlike standard approaches that may only target known nitrosamines, our methods are designed to detect both known and potentially unknown nitrosamine impurities. This pre-emptive strategy not only addresses current regulatory requirements but also anticipates future regulatory expansions as new nitrosamine impurities are discovered. By employing a broader detection scope, our methodologies ensure pharmaceutical companies are better prepared for emerging challenges.
Robust Validation and Training Programs: We have established rigorous validation protocols that ensure our methods are reproducible and reliable across various settings. Additionally, our comprehensive training programs for analysts and technicians emphasize proficiency in the latest analytical techniques and regulatory compliance, thereby enhancing the overall quality of pharmaceutical testing.