Introduction
Nitrosamine contamination has become a critical issue in pharmaceuticals, food, and environmental products. As a leader in analytical testing, ResolveMass Laboratories Inc. ensures the highest quality of Nitrosamine Testing Methods to safeguard public health and regulatory compliance. In this learn with us series, we will explore the Top 5 Nitrosamine Testing Methods (1. LC-MS, 2. GC-MS, 3. HRMS, 4. GC-TEA, 5. UV) every scientist, manufacturer, and quality control specialist should understand.
The rise in nitrosamine contamination has prompted global regulatory agencies like the FDA, EMA, and Health Canada to mandate stringent testing. Nitrosamine Testing Methods are crucial for detecting trace levels of carcinogenic compounds to ensure product safety. ResolveMass Laboratories Inc. is proud to lead the way with state-of-the-art instrumentation and decades of analytical expertise in Nitrosamine Testing Methods.
Why Nitrosamine Testing Methods Are Critical Today
Nitrosamines, such as NDMA and NDEA, are potent carcinogens found in various products through manufacturing processes. Rigorous Nitrosamine Testing Methods are necessary to:
- Meet regulatory requirements
- Protect consumers
- Maintain brand reputation
Learn more about our Nitrosamine Analysis services designed for pharmaceutical, food, and environmental testing.
Top 5 Nitrosamine Testing Methods You Should Know
1. LC-MS/MS (Liquid Chromatography with Tandem Mass Spectrometry)
LC-MS/MS is currently the gold standard among Nitrosamine Testing Methods due to its exceptional sensitivity (ppb or even ppt levels).
- Strengths: High selectivity, quantitation of multiple nitrosamines simultaneously
- Applications: Pharmaceutical APIs, finished products, water testing
At ResolveMass Laboratories Inc., our validated LC-MS/MS testing protocols ensure fast turnaround times and unmatched precision.
2. GC-MS (Gas Chromatography-Mass Spectrometry)
GC-MS remains one of the most trusted Nitrosamine Testing Methods, especially for volatile nitrosamines.
- Strengths: Excellent for volatile compounds, broad screening capabilities
- Applications: Environmental testing, food safety monitoring
ResolveMass Laboratories Inc. combines GC-MS and LC-MS/MS to deliver comprehensive nitrosamine profiling.
3. High-Resolution Mass Spectrometry (HRMS)
HRMS offers ultra-high accuracy and is increasingly preferred for unknown or emerging nitrosamine identification.
- Strengths: Detection of novel nitrosamines
- Applications: Research and regulatory submissions
Our team continuously integrates HRMS into our advanced nitrosamine analysis service portfolio.
4. GC-TEA (Gas Chromatography-Thermal Energy Analyzer)
Among the specialized Nitrosamine Testing Methods, GC-TEA is highly selective for nitroso-compounds.
- Strengths: Specific for N-nitroso structures
- Applications: Tobacco analysis, cosmetic product safety
ResolveMass Laboratories ensures the right testing method based on matrix and regulatory needs. Explore more.
5. UV Spectrophotometry after Derivatization
Although not as sensitive, UV spectrophotometry offers a quick screening method for high-level contamination.
- Strengths: Cost-effective for preliminary analysis
- Applications: Bulk material screening
We provide tailored solutions including UV methods depending on your project. Partner with us for comprehensive options.
Real-Time Case Study: Success with LC-MS/MS Nitrosamine Testing
Client: Global Pharmaceutical Company
Challenge: Potential NDMA contamination detected during routine stability testing.
Solution: ResolveMass Laboratories rapidly deployed Nitrosamine Testing Methods using validated LC-MS/MS protocols.
Outcome:
- Testing completed within 72 hours
- NDMA detected at 28 ppb (below ICH M7 threshold)
- Immediate regulatory compliance report generated
- Zero delays in product launch
Fact: By avoiding a 2-month delay, the client saved approximately $3.2 million in potential lost revenue.
Want to see how we can support your project? Contact us.
Conclusion
Choosing the right Nitrosamine Testing Methods is critical for product safety, regulatory compliance, and protecting brand reputation. ResolveMass Laboratories Inc. leverages world-class expertise in Nitrosamine Testing Methods such as LC-MS/MS, GC-MS, and HRMS to deliver trustworthy, accurate results. Trust ResolveMass for your nitrosamine testing needs. Connect with our experts today!
ResolveMass Laboratories Inc.: Experience, Expertise, and Trust You Can Count On
ResolveMass Laboratories Inc. is a leading name in nitrosamine testing across the United States and Canada. With over a decade of experience, our PhD-level scientists specialize in Mass Spectrometry and nitrosamine impurity chemistry. We offer complete in-house solutions, including risk assessment, confirmatory analysis, regulatory documentation, and expert consultation. As one of the few Canadian CROs, we also provide custom synthesis of rare nitrosamine impurities unavailable elsewhere. Our commitment to advanced technology and regulatory compliance ensures accurate results and trusted partnerships. Choose ResolveMass Laboratories for precise and transparent nitrosamine testing services.
Ready to Get Started?
📩 Contact our expert team
📞 Request a quote for method development
📅 Book a consultation with our scientists
🧪 Submit your sample for testing
References
- EMA. (2021). Assessment and Mitigation of Nitrosamine Risk in Human Medicines. https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-assessment-report_en.pdf
- FDA. (2021). Control of Nitrosamine Impurities in Human Drugs. https://www.fda.gov/media/141720/download
- Health Canada. (2020). Guidance on Nitrosamine Impurities in Medications. https://www.canada.ca/en/health-canada/services/drugs-health-products.html
- ICH. (2023). ICH M7(R2) – Control of Mutagenic Impurities. https://database.ich.org/sites/default/files/M7_R2_Guideline_Step4_2023_0223.pdf
FAQs on Nitrosamine Testing Methods
1. What are Nitrosamines?
Nitrosamines are chemical compounds classified as probable human carcinogens. They can form during manufacturing or storage processes.
2. Why is Nitrosamine Testing Important?
Nitrosamine testing ensures that pharmaceutical, food, and consumer products are safe from carcinogenic contaminants.
3. What is the Most Reliable Nitrosamine Testing Method?
LC-MS/MS is the most sensitive and reliable Nitrosamine Testing Method currently used globally.
4. How Sensitive are LC-MS/MS Tests?
Modern LC-MS/MS systems can detect nitrosamines at levels as low as parts per trillion (ppt).
5. When Should Nitrosamine Testing Be Conducted?
Ideally, nitrosamine testing should be performed during early product development and regularly through production.
6. What Are the Common Nitrosamines Detected?
Common examples include NDMA, NDEA, NMBA, and DIPNA.
7. Can ResolveMass Laboratories Handle High-Sample Volume Projects?
Absolutely. We specialize in high-throughput testing with expedited turnaround times. Request a quote.
8. How Much Does Nitrosamine Testing Cost?
Testing costs vary based on sample complexity and method used. Contact us for customized quotes. Get pricing details.
9. Is Nitrosamine Testing Mandatory?
In many cases, yes—especially for pharmaceuticals regulated under ICH M7 guidelines.
10. How Do I Get Started with Nitrosamine Testing at ResolveMass?
It’s simple! Visit our Nitrosamine Analysis Services page or contact us directly.
