Introduction
In today’s regulatory landscape, nitrosamine testing in US has become essential for pharmaceutical manufacturers. Standard testing methods published by various regulatory authorities like FDA, Health Canada and EMA are effective in many cases, but sometimes fall short when unique formulations or rare nitrosamine impurities are involved. That’s where custom nitrosamine testing solutions in US come into play. At ResolveMass Laboratories Inc., we specialize in providing customized, regulatory-compliant nitrosamine testing services tailored to the specific needs of each client, ensuring no impurity goes undetected.
Why Standard Nitrosamine Testing May Not Be Enough
While standard protocols for nitrosamine testing in US (such as those published by FDA, EMA, and USP) offer a strong foundation, they often cannot cover:
- Complex drug matrices
- Low-level detection requirements
- Rare or newly identified nitrosamines
- Modified-release formulations
- Biopharmaceuticals with reactive precursors
When faced with these challenges, generic testing approaches may lead to incomplete impurity profiles, risking non-compliance and delayed product approvals.
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What Makes Custom Nitrosamine Testing Critical?
Custom nitrosamine testing in US involves adapting sample preparation, chromatographic methods, and detection strategies to your specific product type. Key advantages include:
- Higher sensitivity (LOD and LOQ optimization)
- Broader analyte coverage
- Reduced false positives/negatives
- Faster regulatory responses
At ResolveMass Laboratories Inc., our PhD-level scientists design tailored LC-MS/MS, GC-MS/MS, and HRMS methods based on your product’s chemistry and regulatory needs.
Learn more about our LC-MS/MS capabilities →
ResolveMass Laboratories Inc.: Leaders in Custom Nitrosamine Testing in US
ResolveMass Laboratories brings over a decade of practical experience in nitrosamine testing in US. Our laboratory:
- Offers full in-house analytical services (risk assessment, confirmatory analysis, regulatory consulting)
- Utilizes cutting-edge triple quadrupole and Orbitrap systems
- Has experience handling over 500+ projects for US FDA, Health Canada, and international submissions
- Custom synthesizes rare nitrosamine standards if not commercially available
See our complete Nitrosamine Risk Assessment Services →
Real-World Case Study: Custom Nitrosamine Testing Success
Case Study: A US-based client manufacturing an extended-release formulation faced a challenge detecting Nitroso-Vildagliptin at <10 ppb level.
- Standard methods failed due to matrix interferences.
- ResolveMass Laboratories developed a custom LC-MS/MS method with modified ionization settings.
- LOD achieved: 3 ppb.
- Turnaround Time: 12 working days.
- Outcome: The client successfully filed a Type II DMF amendment without regulatory queries.
This case highlights why investing in custom nitrosamine testing in US can be critical for fast, smooth regulatory pathways.
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Our Custom Testing Workflow
- Project Discussion
- Matrix Evaluation
- Custom Method Development
- Method Validation (ICH Q2 compliant)
- Routine Testing and Regulatory Reporting
Discover our full Custom Nitrosamine Testing Process →
How to Get Started with Custom Nitrosamine Testing in US
If your project demands high precision, quick turnaround, and regulatory-ready documentation, ResolveMass Laboratories is your ideal partner for nitrosamine testing in US.
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FAQs on Custom Nitrosamine Testing in US
Q1. Why do I need custom nitrosamine testing in US instead of standard testing?
A1. Standard methods may miss certain nitrosamines in complex matrices or new formulations. Custom testing ensures precise detection and regulatory compliance.
Q2. What instruments are used for custom nitrosamine testing?
A2. At ResolveMass Laboratories, we use LC-MS/MS, GC-MS/MS, HRMS systems, optimized per project needs.
Q3. How long does custom nitrosamine testing take?
A3. Method development typically takes 2–4 weeks, and testing 1–2 weeks depending on complexity.
Q4. Is custom nitrosamine testing in US accepted by FDA and Health Canada?
A4. Yes, our validated methods meet ICH Q2(R1) and regulatory expectations for global submissions.
Q5. Can you develop methods for newly identified nitrosamines?
A5. Absolutely! We specialize in rare nitrosamine detection, including custom synthesis of reference standards if needed.
Q6. What is the detection limit achievable with custom testing?
A6. Depending on the compound and matrix, LODs as low as 1–3 ppb can be achieved.
Q7. Do you offer risk assessment support along with nitrosamine testing?
A7. Yes, we offer end-to-end solutions including nitrosamine risk assessments.
Q8. Can you handle API, intermediate, and finished dosage forms?
A8. Yes, we have validated protocols for APIs, drug products, and excipients.
Q9. How much does custom nitrosamine testing in US cost?
A9. Pricing varies depending on project complexity, but we offer transparent, competitive quotes.
Q10. How do I request a quote for custom nitrosamine testing in US?
A10. Simply contact us through our website, and one of our scientists will assist you within 24 hours.
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
