In recent years, nitrosamines have emerged as a critical concern in pharmaceutical quality control. Even in trace amounts, these compounds have triggered global drug recalls and regulatory crackdowns by health authorities such as the FDA, EMA, and WHO.
But what exactly are nitrosamines? Why are they dangerous in medications? And how can pharmaceutical companies detect and eliminate them?
Nitrosamines are a class of chemical compounds with the general structure R¹N(-R²)-N=O. Many are classified as probable human carcinogens by the International Agency for Research on Cancer (IARC).
These compounds can form under specific conditions—particularly during chemical synthesis, storage, or when certain ingredients degrade over time.
The issue gained global attention after the 2018 recall of valsartan, a popular blood pressure medication, due to unacceptable levels of NDMA. Since then, regulators have launched sweeping reviews across various drug classes.
Nitrosamines can be introduced through multiple pathways:
This complexity demands comprehensive risk assessments and advanced analytical methods.
At Spectrasynth, we partner with pharmaceutical companies to mitigate nitrosamine threats through advanced tools, testing, and regulatory support.
Nitrosamine contamination is a serious challenge—but one that can be managed with the right scientific expertise and compliance tools.
Contact Spectrasynth today to learn how we can support your organization in meeting regulatory standards and ensuring product safety.