Unseen Threats: Nitrosamine Impurities in Pharmaceuticals

10. September 2025

See this article by Vikram Thermo: A Sudden Jolt: When the Medicine Became the Risk In July 2018, the pharmaceutical...

Development and Application of Analytical Methods to Quantitate Nitrite in Excipients and Secondary Amines in Metformin API at Trace Levels Using Liquid Chromatography–Tandem Mass Spectrometry

25. August 2025

Abstract Nitrosamine impurities have provoked numerous global medicine recalls due to their possible presence during drug manufacturing or storage. Regarding...

Nitrite testing in excipients – Industry best practices

21. August 2025

Abstract NNitrosamine risk assessment and control are essential components of pharmaceutical drug development and product evaluation. Nitrites present in excipients...

ZoomLab® with integrated Nitrosamine Risk Assessment and Mitigation’ app

20. August 2025

BASF has news for drug formulators! They introduced a new ‘Nitrosamine Risk Assessment and Mitigation’ app in ZoomLab®, their Virtual...

Nitrosamine formation in Lidocaine active pharmaceutical ingredients and drug products

10. August 2025

Abstract N-nitrosamine compounds have long been known for their carcinogenic properties, but they came into the focus of the pharmaceutical...

The Nitrosamine challenge in pharmaceuticals

24. July 2025

Since 2018 the risk of nitrosamine impurities in medicinal products has become a critical concern for pharmaceutical manufacturers and regulators...

Deriving safe limits for N-nitroso-bisoprolol by error-corrected next-generation sequencing (ecNGS) and benchmark dose (BMD) analysis, integrated with QM modeling and CYP-docking analysis

14. June 2025

Abstract N-nitroso-bisoprolol (NBP) is a nitrosamine drug substance-related impurity (NDSRI) of bisoprolol, which is used to treat cardiac diseases since...

Nitrosamine