Introduction
The quantification of trace nitrosamines with GC-MS (Gas Chromatography-Mass Spectrometry) has become a critical analytical method across pharmaceutical, food, and environmental industries. Quantification of these carcinogenic compounds at very low levels ensures product safety, and public health. At ResolveMass Laboratories Inc., our years of real-world experience with PhD level Scientists, advanced instrumetns, and commitment to scientific excellence make us a trusted leader in GC-MS nitrosamine quantification.
Explore our nitrosamine analysis services here ➔
What Are Nitrosamines?
Nitrosamines are a class of chemical compounds, many of which are potent carcinogenic impurities. They can form during manufacturing processes, particularly when secondary or tertiary amines react with nitrosating agents under specific conditions. Common sources include:
- Pharmaceuticals (e.g., angiotensin receptor blockers)
- Food products (e.g., cured meats)
- Cosmetics
- Tobacco smoke
Given the potential health risks, regulatory bodies like the FDA, EMA, and Health Canada have set stringent limits on nitrosamine levels in consumable products. This makes GC-MS nitrosamine quantification essential.
Why Choose GC-MS for Nitrosamine Quantification?
High Sensitivity and Selectivity
GC-MS offers unparalleled sensitivity for detecting nitrosamines at the parts-per-billion (ppb) or even parts-per-trillion (ppt) level, critical for compliance and safety assessments.
Regulatory Acceptance
Major health authorities recognize and prefer GC-MS nitrosamine quantification due to its accuracy and reproducibility.
Learn how our nitrosamine testing aligns with regulatory guidelines ➔
Complex Matrix Compatibility
Pharmaceutical formulations, food samples, and environmental matrices often complicate nitrosamine analysis. GC-MS overcomes matrix interferences, providing clean, accurate data.
When Is GC-MS Nitrosamine Quantification Used?
1. Drug Product Testing
Pharmaceutical companies use GC-MS nitrosamine quantification to ensure medications are free from unacceptable nitrosamine levels, especially after contamination recalls.
2. Manufacturing Process Validation
Monitoring raw materials, intermediates, and final products helps manufacturers identify nitrosamine formation risks and control them proactively.
Discover our expertise in pharmaceutical nitrosamine testing ➔
3. Food Safety
GC-MS is vital in verifying compliance in processed meats, beer, and dairy, where nitrosamines could form during preservation or cooking.
4. Environmental Monitoring
Trace analysis of water, soil, and air samples for nitrosamines helps industries comply with environmental regulations.
How GC-MS Works in Nitrosamine Quantification
Sample Preparation
Careful extraction and purification techniques prevent artifact formation and improve nitrosamine recovery from complex matrices.
Chromatographic Separation
GC separates volatile nitrosamines efficiently before they enter the mass spectrometer.
Mass Spectrometry Detection
Highly specific mass-to-charge ratios (m/z) enable the precise identification and quantification of individual nitrosamines, even at trace levels.
Our state-of-the-art GC-MS systems ➔
Real-World Case Study: Pharmaceutical Nitrosamine Testing
Challenge:
A global pharmaceutical company discovered potential nitrosamine contamination (NDMA and NDEA) in a popular blood pressure drug. Regulatory agencies demanded rapid, reliable quantification using GC-MS.
Solution:
The company partnered with ResolveMass Laboratories Inc. for GC-MS nitrosamine quantification.
- Method developed and validated within 1-2 weeks.
- Limits of Detection (LOD): < 0.5 ppm
- Analyzed 50+ product batches within 2 weeks
- 98.5% batches cleared for regulatory compliance
Outcome:
The client avoided a full-scale product recall, saving overall cost and preserving patients safety.
Get a custom consultation for your project ➔
Why Trust ResolveMass Laboratories Inc.?
- Experience: Decades of hands-on analytical expertise.
- Expertise: Specialized in complex trace analysis, especially GC-MS nitrosamine quantification.
- Authoritativeness: Trusted partner for regulatory submission projects.
- Trustworthiness: ISO/IEC 17025 accredited laboratory.
FAQs on GC-MS Nitrosamine Quantification
1. What is GC-MS nitrosamine quantification?
GC-MS nitrosamine quantification is a method used to detect and measure trace levels of nitrosamines in various matrices using Gas Chromatography-Mass Spectrometry.
2. Why are nitrosamines dangerous?
Many nitrosamines are classified as probable human carcinogens. Long-term exposure increases cancer risk.
3. How sensitive is GC-MS for nitrosamines?
GC-MS can detect nitrosamines at parts-per-billion (ppb) or even parts-per-trillion (ppt) levels, ensuring ultra-trace sensitivity.
4. Which industries require nitrosamine testing?
Pharmaceutical, food, environmental, and cosmetic industries all need GC-MS nitrosamine quantification to ensure safety and regulatory compliance.
5. How fast can results be obtained?
At ResolveMass, standard turnaround is 5-7 business days. Expedited services are available for urgent cases.
6. What sample types can be tested?
Tablets, capsules, API powders, water samples, food matrices, and even packaging materials can be tested using GC-MS.
7. What is the detection limit for NDMA using GC-MS?
Using optimized methods, GC-MS can detect NDMA levels as low as 0.1 ppb in pharmaceuticals.
8. Can GC-MS distinguish between different nitrosamines?
Yes, GC-MS allows the simultaneous quantification of multiple nitrosamines in a single run.
9. How to ensure sample integrity during testing?
Proper sample storage (cold chain if necessary) and prompt shipment minimize the risk of nitrosamine degradation.
10. Why choose ResolveMass Laboratories Inc. for GC-MS nitrosamine testing?
We offer validated, regulatory-compliant methods, rapid turnaround, deep scientific expertise, and personalized client support.
Schedule your nitrosamine analysis now ➔
Conclusion
The quantification of trace nitrosamines with GC-MS is a cornerstone of product safety and regulatory compliance across multiple industries. From pharmaceuticals to environmental monitoring, this technique ensures that carcinogenic risks are identified, quantified and mitigated early. Partnering with experts like ResolveMass Laboratories Inc. guarantees not only accurate results but also the confidence to move forward safely and successfully.
Ready to ensure your products meet the highest safety standards?
Contact ResolveMass Laboratories Inc. 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
