August 27th, 2025
3 min to read
Nitrosamine Impurities in Pharmaceuticals: How LabSense Ensures Safety and Compliance
Nitrosamines are a class of chemical compounds that have raised significant concern in the pharmaceutical industry due to their carcinogenic potential. Since 2018, when nitrosamine impurities such as NDMA and NDEA were first detected in certain sartan medicines, regulators including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have introduced strict acceptable intake (AI) limits.
These findings highlighted the urgent need for sensitive, validated analytical methods capable of detecting nitrosamines at trace levels in both active pharmaceutical ingredients (APIs) and finished products.
Nitrosamines can be introduced into pharmaceutical products through different pathways, typically divided into two main groups:
Regulators worldwide require:
At LabSense, we have developed advanced analytical workflows specifically designed to detect and quantify nitrosamine impurities:
Our services are designed to support pharmaceutical companies in meeting regulatory expectations, ensuring market compliance, and, above all, protecting patient safety.
Nitrosamine testing is no longer optional – it is a regulatory and patient safety requirement. With its specialized capabilities, LabSense provides pharmaceutical manufacturers with the tools and expertise needed to detect, quantify, and control nitrosamine impurities.
📩 Contact us today to learn more about our nitrosamine detection services and how we can help you safeguard your products and maintain compliance in a demanding regulatory landscape. For more information contact us here.
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