Dipharma Announces Groundbreaking Research in Nitrosamine Detection
Dipharma Francis S.r.l., a prominent Contract Development and Manufacturing Organization and global manufacturer of Active Pharmaceutical Ingredients, has announced the publication of a significant peer-reviewed study in the scientific journal Organic Process Research & Development. The open-access article, titled "Hunt for NDSRIs: Unveiling Hidden Threats with the Novel 15N-Enriched NAP Test," was published on November 27, 2025.
A Novel Approach to Pharmaceutical Safety
The research outlines an innovative method developed by Dipharma's scientific team to detect nitrosamine impurities, specifically nitrosamine drug-substance-related impurities. These small nitrogen-based compounds can form unintentionally during the synthesis, storage, or degradation of pharmaceutical products. Their control is critically important, as many nitrosamines are potent mutagens and probable human carcinogens, posing significant risks to patient safety.
The new strategy effectively overcomes the limitations of traditional mass-based analytical techniques. It integrates the nitrosation assay procedure with 15N-enriched nitrosating reagents and 15N NMR spectroscopy. This combination provides a highly selective and sensitive technique for detecting and characterizing nitrosamines, even when dealing with complex matrices, isomeric species, or impurities derived from degradation.
Implications for the Pharmaceutical Industry
This publication represents a substantial advancement for both innovator and generic pharmaceutical companies. The method serves as a robust, early-stage tool for assessing nitrosamine formation risk during API development and manufacturing. It supports comprehensive impurity profiling, enhances process understanding, and helps ensure alignment with evolving regulatory expectations from health authorities worldwide.
Gabriele Razzetti, Global Director of R&D at Dipharma, emphasized the importance of this achievement. He stated that this research strengthens the company's long-term strategy for nitrosamine control, which is grounded in multidisciplinary scientific investigation. The approach combines advanced analytical solutions with a robust Risk Assessment Protocol and proactive measures designed to safeguard compliance and product safety.
Razzetti further explained that this innovative method allows Dipharma to confirm or exclude nitrosamine formation with exceptional clarity, even in the most complex scenarios. For the company's partners, this provides a reliable foundation for risk assessment, regulatory justification, and mitigation planning. It also reinforces confidence that Dipharma is fully aligned with objectives for safe, robust, and future-proof API manufacturing.
The research team included Anna Simonetto, R&D Researcher; Gabriele Razzetti, Global Director of R&D; and Simone Mantegazza, Research Laboratory Manager, at Dipharma Francis, in collaboration with Prof. Enrico Monzani at the University of Pavia in Italy.
The full study is freely accessible to scientists and industry stakeholders at: https://pubs.acs.org/doi/10.1021/acs.oprd.5c00223
