Summary
- Mass Spectrometry Experts for Nitrosamine Testing apply advanced techniques to ensure precise, reliable, and regulatory-compliant results.
- ResolveMass Laboratories Inc. is a leading authority in mass spectrometry, specializing in nitrosamine and NDSRI detection.
- The blog covers analytical methodologies, instrument technologies, and the scientific expertise behind nitrosamine and novel drug substance-related impurity (NDSRI) detection.
- We discuss the critical role of high-resolution mass spectrometry, sample preparation, and data analysis in enhancing detection sensitivity and specificity.
- Readers will learn about the advantages of ResolveMass’s integrated testing services including extractables & leachables, direct infusion, and impurity profiling.
- FAQs provide detailed scientific insights answering the most pertinent questions by industry professionals.
Introduction – Mass Spectrometry Experts for Nitrosamine Testing
ResolveMass Laboratories Inc. is trusted worldwide as Mass Spectrometry Experts for Nitrosamine Testing, offering precise and reliable analysis for pharmaceutical companies. Our goal is to detect nitrosamines and novel impurities (NDSRIs) at the lowest possible levels, ensuring patient safety and helping manufacturers meet strict regulatory requirements. By using advanced mass spectrometry systems, proven scientific methods, and regulatory-compliant workflows, we provide accurate results that give confidence to both industry and authorities.
This article explains how our laboratory applies modern analytical techniques, advanced sample preparation methods, and integrated workflows to achieve high-quality testing. It also highlights why pharmaceutical developers, researchers, and regulators rely on us when safety and compliance cannot be compromised.
Why Choose ResolveMass as Your Mass Spectrometry Experts for Nitrosamine Testing?
At ResolveMass, we go beyond routine testing. Our laboratory combines deep expertise and state-of-the-art instruments to deliver clear, dependable results. We understand that nitrosamines and NDSRIs can appear in drug substances, excipients, or even packaging, which is why every project is customized to address the unique risks of each product.
Our advantages include:
- Use of advanced Orbitrap and triple quadrupole LC-MS/MS systems.
- Comprehensive service portfolio including bioanalytical quantification, nitrosamine analysis, peptide characterization, and proteomics.
- Compliance with FDA, EMA, and ICH international guidelines.
- A multidisciplinary team of chemists, biochemists, and analysts.
- Flexible method development tailored to specific client needs.
By choosing ResolveMass, clients can speed up regulatory submissions, reduce risks, and ensure complete safety in every stage of drug development.
Understanding Nitrosamines and NDSRIs
Nitrosamines are well-known for their cancer-causing potential and are considered dangerous even at trace levels. They may form during drug manufacturing, from chemical interactions, or through storage conditions. NDSRIs (Novel Drug Substance-Related Impurities) are a newer concern that arise directly from active pharmaceutical ingredients, often requiring deeper investigation.
| Key Points | Nitrosamines | NDSRIs |
|---|---|---|
| Toxicity | Carcinogenic | Variable toxicological profiles |
| Occurrence | Drug intermediates, packaging | Drug degradation or synthesis byproducts |
| Regulatory Limits | Extremely low (ppt to ppb) | Strict pre-approval thresholds |
| Analytical Requirement | Ultra-trace detection | Structural elucidation and quantification |
Advanced Techniques by Mass Spectrometry Experts for Nitrosamine & NDSRI Detection
- High-Resolution Mass Spectrometry (HRMS)
- Orbitrap and Q-TOF systems provide unmatched resolution and mass accuracy.
- Helps identify unknown impurities with confidence.
- Improves sensitivity in complex drug formulations.
- Detects emerging nitrosamines early, before they become regulatory issues.
Explore our mass spectrometry experts page for more on our HRMS capabilities.
2. Tandem Mass Spectrometry (LC-MS/MS)
- Recognized as the gold standard for quantitative nitrosamine testing.
- Uses multiple reaction monitoring (MRM) for high specificity.
- Ensures accurate quantification at ultra-trace levels.
- Capable of detecting multiple nitrosamines in a single run.
Learn about our impurity profiling and nitrosamine analysis services.
3. Advanced Sample Preparation
- Reduces analytical errors and improves reproducibility.
- Methods include Solid Phase Extraction (SPE) and Liquid-Liquid Extraction (LLE).
- Use of isotope-labeled standards ensures accuracy.
- Customized to match specific drug formulations and packaging materials.
Visit our bioanalytical quantification section for details on method development.
4. Direct Infusion Mass Spectrometry
- Speeds up impurity screening by skipping chromatography steps, especially useful for rapid impurity profiling.
- Ideal for early-stage projects needing fast turnaround.
- Provides high-throughput results with minimal sample prep.
- Complements LC-MS/MS for a more complete testing strategy.
Integrated Mass Spectrometry Services for Compliance
ResolveMass goes beyond detection — we deliver compliance-ready solutions. Our workflows are fully aligned with international guidelines, including FDA, EMA, and ICH requirements. Clients also benefit from detailed reporting, complete with validation data and regulatory insights.
In addition to nitrosamine analysis, we provide related services such as extractables and leachables testing, impurity profiling, peptide sequencing, proteomics, and PFAS analysis. This integrated service model allows pharmaceutical companies to manage multiple testing needs through a single trusted partner.
Summary Table: ResolveMass Techniques for Nitrosamine & NDSRI Detection
| Technique | Application | Advantages |
|---|---|---|
| High-Resolution MS | Structural elucidation, unknown screening | Ultra-high mass accuracy, confident ID |
| LC-MS/MS | Quantitative nitrosamine detection | High sensitivity, regulatory compliance |
| Direct Infusion MS | Rapid impurity screening | High throughput |
| Sample Preparation (SPE, LLE) | Concentration, cleanup | Artifact reduction, matrix simplification |
Why Trust ResolveMass Laboratories?
- Expertise – A team of skilled scientists recognized globally for their work in impurity testing and regulatory collaboration.
- Reliability – Trusted by pharmaceutical leaders for delivering accurate, consistent, and validated results.
- Transparency – Clear reporting and easy-to-understand explanations that simplify complex data.
- Commitment – Focused on providing clarity, compliance, and confidence in every project.
- Long-Term Partnership – Dedicated to being a reliable partner in ensuring pharmaceutical safety.
Conclusion: Partner with Mass Spectrometry Experts for Nitrosamine Testing
ResolveMass Laboratories is proud to be recognized as Mass Spectrometry Experts for Nitrosamine Testing, supporting global pharmaceutical companies with precision-driven, regulatory-compliant services. From high-resolution mass spectrometry to advanced sample preparation and direct infusion workflows, our laboratory delivers results that protect patient health and accelerate market approval.
By working with us, clients gain more than testing data — they gain a reliable partner committed to safety, compliance, and innovation in every project.
Frequently Asked Questions (FAQs)
Mass spectrometry is the best choice because it can detect nitrosamines even at extremely low levels, often in parts-per-billion. Techniques like HRMS and LC-MS/MS give very precise results, which is essential for meeting strict safety and regulatory requirements.
Yes. Advanced HRMS technology allows us to identify and study unknown NDSRIs in detail. Detecting them early helps pharmaceutical companies manage risks, improve safety, and meet regulatory expectations during drug development.
Absolutely. LC-MS/MS is widely used for routine nitrosamine testing because it allows fast, repeatable, and sensitive results. This makes it suitable for long-term monitoring required by regulators.
The timeline depends on the type of sample and project needs. However, thanks to our advanced workflows and skilled team, we provide quick turnaround while still maintaining the highest quality standards.
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References
- Martins, D. N., Vendramini, P. H., Simionato, A. V. C., & Sussulini, A. (2022). Introduction to bioanalytical mass spectrometry. In L. T. Kubota, J. A. F. da Silva, M. M. Sena, & W. A. Alves (Eds.), Tools and trends in bioanalytical chemistry (pp. 317–338). Springer. https://doi.org/10.1007/978-3-030-82381-8_23
- Klont, F., & Hopfgartner, G. (2021). Mass spectrometry-based approaches and strategies in bioanalysis for qualitative and quantitative analysis of pharmaceutically relevant molecules. Drug Discovery Today: Technologies, 40, 64–68. https://doi.org/10.1016/j.ddtec.2021.10.004
