United for safety – why Nitrosamine control matters

Nitrosamines (N-nitroso compounds) are a class of chemical impurities that have drawn global regulatory attention because they are classified as probable human carcinogens and are subject to heightened scrutiny in pharmaceutical products. Trace amounts of nitrosamines have been detected in certain medications during post-market surveillance, prompting authorities such as the FDA and the European Medicines Agency (EMA) to issue updated requirements for comprehensive risk mitigation and compliance strategies. 

While APIs often receive the most attention, excipients can significantly contribute to nitrosamine formation risk by: 

Selecting excipients with documented low nitrite levels and controlled variability is a recognized and regulator-aligned mitigation strategy. 

Low-nitrite excipients are designed to be functionally equivalent to standard grades, enabling: 

IMCD offers science-driven expertise in the field of nitrosamines, helping customers understand a complex topic with confidence while maintaining a strong focus on quality and safety. As a trusted supplier of a wide range of APIs and excipients, we offer well-characterised, reliable materials that support robust formulation and informed decision-making at every stage of development. Whether you are exploring nitrosamine-related considerations or simply searching for the right ingredient, our guidance makes it easier to find exactly what you need.