Nitroso API Analysis and Monitoring

These pharmaceutical active ingredients have gained critical relevance following regulatory updates, including the EMA/409815/2020 Rev. 18 on October 2, 2023, which introduced new directives and limits for monitoring nitrosamines, including those potentially generated by the APIs themselves.

Our invaluable commitment to research and analysis of Nitroso API places us in a leadership position in this field. We recognize the responsibility to ensure the highest safety in pharmaceutical products and compliance with the strict restrictions imposed by regulatory authorities.

Neotron offers a wide range of services to support pharmaceutical companies, including:

• Analytical Method Development (R&D): We develop customized analysis methods to meet the unique needs of our clients.
• Method Screening and Validation: Using advanced analytical techniques such as GC-MS, HPLC-MS, and LC-TOF, we accurately detect the presence of nitrosamines in APIs, drugs, and excipients.

We stand out for our promptness and responsiveness in nitrosamine screening processes, as well as our proactiveness in conducting advanced studies on new Nitroso APIs. These distinctive features make us a reliable partner for pharmaceutical companies seeking to ensure the safety and compliance of their products.

To stay continuously informed about the latest developments regarding nitrosamines and Nitroso APIs, we invite you to explore our table of reference nitrosamines and their relative limits by downloading the document below: