Nitrosamine Testing

Nitrosamines, a class of potentially carcinogenic compounds, have garnered significant attention in recent years due to their presence in certain pharmaceutical samples. Understanding and effectively testing for nitrosamines is paramount to ensuring the safety and quality of drug products.

We perform Nitrosamine testing studies for

• We provide high throughput approach for routine screening
• Our consolidated scientific solutions ensure customers get streamlined support across functions
• Our team is well versed and stay up-to-date with respect to regulatory guidelines and methods.
For accurate and reliable results our team works with best-in-class equipment, including LC-MSMS and GC-MSMS systems.
• We have rich experience with nitrosamine testing, including method development, validation and batch analysis.

Why Test for Nitrosamines in Drug Products?
The presence of nitrosamines in drug products poses a considerable risk to public health. Regulatory agencies worldwide have implemented stringent guidelines and regulations mandating the testing and control of nitrosamine levels in pharmaceuticals. Detecting and quantifying nitrosamines in drug products is crucial for ensuring compliance with regulatory standards and safeguarding patient safety.

Methods of Nitrosamine and Nitrosamine drug substance related impurities (NDSRI’S) Testing:
• Liquid Chromatography-Mass Spectrometry (LC-MS): LC-MS is a powerful analytical technique capable of detecting and quantifying trace levels of nitrosamines with high sensitivity and specificity. This technique is widely used in pharmaceutical laboratories for nitrosamine analysis.

• Gas Chromatography-Mass Spectrometry (GC-MS): GC-MS is another effective technique for nitrosamine testing, particularly for volatile compounds. It offers excellent separation and detection capabilities, making it suitable for a wide range of drug products.

• High-Performance Liquid Chromatography (HPLC): HPLC coupled with ultraviolet (UV) or fluorescence detection is commonly used for nitrosamine analysis in pharmaceuticals. This method provides reliable results and is relatively easy to implement in laboratory settings.

Regulatory Requirements and Guidelines:
Regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have issued guidelines and regulations for nitrosamine and nitrosamine drug substance -related impurities (NDSRI’S) testing in drugs. Compliance with these requirements is essential for pharmaceutical manufacturers to ensure product safety and regulatory approval.

At Eurofins BioPharma Product Testing (Eurofins BPT) we understand that the Nitrosamine testing is a critical aspect of pharmaceutical quality control, aimed at protecting public health by preventing exposure to potentially carcinogenic compounds. By implementing robust testing methods and adhering to regulatory guidelines, pharmaceutical companies can mitigate the risk of nitrosamine contamination and ensure the safety and efficacy of their products. Contact us to get your drug substances and drug products testing.