Pushing Boundaries in Nitrosamines Analysis: Spotlight on Nitroso Drug Substance-Related Impurities

Pharmaceutical Laboratory Services - One-stop shop pharma facility.
Mérieux NutriSciences is a valued partner to the global healthcare industry, offering research, development and quality control testing of pharmaceutical products.

From active ingredients to finished products, we offer a complete range of analytical and research services for API and pharmaceutical products.Our services include safety and quality control, development and validation of analytical methods. Our fully equipped, state-of-the-art laboratories offer comprehensive testing services according to the current pharmacopoeia. We also provide tailored solutions according to customer specifications.

Thanks to the long-standing experience, Mérieux NutriSciences has been developing various strategies and approaches for the determination of nitrosamines residues in different matrices through sophisticated mass spectrometry combined with a pool of experts.

Our capabilities: The R&D department of Mérieux NutriSciences | Pharma and Healthcare has developed and/or validated high sensitive methods suitable for more than 70 NDRSIs and small nitrosamines.

Our capabilities - The Viral Clearance Study

Our dedicated virology lab control the viral safety of your product by assessing the capacity of the production processes to clear infectious viruses. The objective of viral clearance studies is to evaluate the ability of the manufacturing process to inactivate/remove known or even unknown viral contaminants, and to estimate process robustness by characterizing its ability to clear different model viruses.

Mérieux NutriSciences performs E&L studies providing a full integrated testing strategy together with toxicological assessment and risk analysis.
Extractables and Leachables studies provide a full-integrated testing strategy together with toxicological assessment and risk analysis, in six main steps:Profiling of extractables: generation of the extractCharacterization of extractablesPrimary and secondary leachables profileUnknown extractables/leachables tentative identification by HRMS techniques (if needed)Toxicological evaluation and risk assessmentDevelopment and validation of targeted methods suitable for the quantification of critical leachables

The presence of foreign particles in sterile pharmaceutical products and/or medical device can affect their safety and efficacy.Foreign particles may originate from both organic and inorganic sources, as corroded or damaged equipment parts, cross contamination during the process, microplastics or from biological sources. The implementation of quality controls for particles can be a good strategy in order to minimize the contamination probability.


Mérieux NutriSciences has developed various strategies and complementary approaches for the identification of foreign visible and subvisible particles, thanks to sophisticated instrumentations combined with a pool of experts in different fields.

In vitro models mimic the different biological barriers and target organs by which it is possible to evaluate absorption and efficacy of formulations. 

Absorption studies permit the performing of several screening tests to preliminarily evaluate products, ingredients or formulations before proceeding with the next steps evaluation.

Mérieux NutriSciences supports you from the initial assessment of your project to the correct identification of the requirements for submitting the dossier to the Commission.We perform all the necessary tests in our labs,and apply for Novel Food authorisation.

Thanks to a valuable pool of experts, Mérieux NutriSciences supports you in the development of the testing plan to determine which studies are necessary to ensure that the device is safe and effective, meeting the essential requirements for affixing the CE mark on the product.Regulatory support and Risk AssesmentQuality Controls and StabiltyBiocompatibilityAbsorption and efficacy studiesHuman factor services