The Hidden Risk in Your Analytical Protocol
Pharmaceutical companies face mounting pressure to detect and quantify nitrosamines – genotoxic impurities that pose serious patient safety risks. But what happens when your testing method creates the very contamination you’re trying to detect?
This isn’t a theoretical concern. False positive results can trigger a cascade of costly consequences: unnecessary product recalls, regulatory scrutiny, financial losses, and most critically, disruptions to the drug supply chain that impact patient access to essential therapies.
Watch: A Breakthrough in Nitrosamine Testing Accuracy
In this video, Resolian analytical scientist Tracy shares groundbreaking research that reveals a critical gap in standard nitrosamine testing protocols—and presents a practical solution that could transform how pharmaceutical companies approach these challenging analyses.
Tracy investigated N-Nitrosopseudoephedrine formation in drug products containing pseudoephedrine and discovered something that many analytical labs may be overlooking: acidic conditions commonly used in sample preparation can actually create nitrosamines during testing, not just detect them.
What You’ll Learn in This Video:
- How nitrosamine formation can occur during analytical testing itself
- Experimental evidence demonstrating the scope of this problem
- A validated solution using Vitamin E as a nitrite scavenger
- Practical implementation guidance for LC-MS/MS methods
- The broader implications for regulatory compliance and patient safety
The research demonstrates that a simple modification to sample preparation protocols can effectively suppress artifact formation without compromising method performance – offering pharmaceutical companies a reliable way to enhance analytical accuracy and avoid costly false alarms.
Why This Matters for Your Testing Program
Nitrosamine testing continues to evolve as regulatory agencies refine their expectations and scientists uncover new analytical challenges. Understanding the potential for artifact formation during sample preparation is essential for:
- Ensuring test results accurately reflect product quality
- Maintaining regulatory compliance with confidence
- Protecting supply chains from unwarranted disruptions
- Preserving patient access to critical medications
Expert Support When You Need It
Having a trusted partner who understands both the chemistry and the compliance landscape is essential when navigating complex analytical challenges like nitrosamine testing.
Resolian’s analytical sciences department specializes in supporting pharmaceutical companies with nitrosamine method development, validation, and troubleshooting. Whether you’re concerned about potential false positives, developing new testing protocols, or investigating unexpected findings, our team brings the expertise to guide you through every step.
Ready to discuss your nitrosamine testing challenges?
Contact our analytical sciences team to learn how we can support your specific needs.
