MILAN, November 28, 2025 — Leads & Copy — Dipharma Francis S.r.l., a leading Contract Development and Manufacturing Organization (CDMO), has announced the publication of an open-access article in the scientific journal Organic Process Research & Development (OPR&D).
The article, titled “Hunt for NDSRIs: Unveiling Hidden Threats with the Novel 15N-Enriched NAP Test,” details a novel approach developed by Dipharma to detect nitrosamine impurities, particularly nitrosamine drug-substance-related impurities (NDSRIs).
Nitrosamines, small nitrogen-based compounds, can form unintentionally during synthesis, storage, or degradation. Many are potent mutagens and probable human carcinogens, making their control essential for patient safety, regulatory compliance, and pharmaceutical supply chain integrity.
The publication is accessible to scientists and industry stakeholders worldwide at https://pubs.acs.org/doi/10.1021/acs.oprd.5c00223. It appears in OPR&D, a peer-reviewed journal by the American Chemical Society (ACS) focused on chemical process development and scale-up for industrial applications.
The article is authored by Anna Simonetto, R&D Researcher, Gabriele Razzetti, Global Director of R&D, and Simone Mantegazza, Research Laboratory Manager, at Dipharma Francis, along with Prof. Enrico Monzani from the University of Pavia (Italy).
The research team’s innovative method overcomes the limitations of traditional mass-based techniques by integrating the nitrosation assay procedure (NAP) with 15N-enriched nitrosating reagents and 15N-NMR spectroscopy. This provides a selective and sensitive technique to detect and characterize nitrosamines, including challenging NDSRIs, even in complex matrices or when dealing with isomeric or degradation-derived species.
This strategy offers a tool for assessing nitrosamine formation during API development and manufacturing, supporting impurity profiling, process understanding, and alignment with evolving regulatory expectations.
Dipharma believes this research represents a significant step forward for innovator and generic pharmaceutical companies in proactively identifying and addressing nitrosamine-related challenges and ensuring long-term product reliability.
Gabriele Razzetti, Global Director of R&D at Dipharma Francis S.r.l., stated that this publication strengthens Dipharma’s long-term strategy for nitrosamine control. The strategy combines advanced analytical solutions, a Risk Assessment Protocol, and proactive measures designed to safeguard compliance and product safety.
Razzetti added that Dipharma’s innovative approach can confirm or exclude nitrosamine formation with exceptional clarity, even in complex scenarios, providing partners with a reliable foundation for risk assessment, regulatory justification, and mitigation planning.
About the Dipharma Francis group
The Dipharma Group is a global CDMO and a leading manufacturer of APIs and Intermediates, with about 600 skilled employees, 4 cGMP plants in the U.S.A. and Italy, and sales offices in Italy, the U.S.A. and China. The company’s R&D Centers develop innovative chemical processes and crystalline forms for pharmaceutical companies worldwide. Dipharma is a third-generation family-owned company with a history of stability, commitment, and financial solidity.
Paola Clerici, Communication Manager
Dipharma Francis S.r.l.
paola.clerici@dipharma.com
Source: Dipharma Francis S.r.l.
