Nitroso API Analysis and Monitoring
Neotron is at the forefront of the pharmaceutical and regulatory industry, providing essential support to address the growing importance of focusing on Nitroso API.
These pharmaceutical active ingredients have gained critical relevance following regulatory updates, including the EMA /409815/2020 Rev.22 of 17 April 2025, which introduced new directives and limits for monitoring nitrosamines, including those potentially generated by the APIs themselves.
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..
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:
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Choose Neotron Pharma to lead you in managing Nitroso APIs and ensuring the safety of your pharmaceutical products. Contact us today.
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To discover how our services can benefit you, or to receive a quotation, please contact us.
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Pharma
Neotron Pharma is a leading European laboratory that provides advanced testing and analysis services for the pharmaceutical industry.
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