As regulatory expectations continue to evolve, pharmaceutical companies are increasingly relying on a Nitrosamine Impurity Testing Company in the United States to support their ANDA (Abbreviated New Drug Application) and NDA (New Drug Application) submissions. Whether you’re a generic manufacturer or an innovator sponsor, nitrosamine impurity assessment is now a mandatory regulatory step.
Choosing a qualified Nitrosamine Impurity Testing Company in the United States can make the difference between timely approval and regulatory setbacks. In this article, we’ll break down why you need such a partner, what services are critical, and how labs like ResolveMass Laboratories provide specialized solutions tailored for U.S. FDA submissions.
Why You Need a Nitrosamine Impurity Testing Company in the United States for Regulatory Success
FDA, EMA, and Health Canada have all issued guidance documents requiring risk assessment and analytical testing for nitrosamines in both drug substances and drug products. For ANDA and NDA submissions in the U.S., it is critical to work with a Nitrosamine Impurity Testing Company in the United States that has:
- Advanced instrumentation (LC-MS/MS, GC-MS, HRMS)
- Regulatory expertise
- Method validation capabilities under ICH Q2 (R1)
- NDSRI (Nitrosamine Drug Substance Related Impurity) synthesis capabilities
ResolveMass Laboratories offers a full spectrum of nitrosamine impurity services designed for U.S. pharmaceutical regulatory pathways.
FDA Expectations and the Role of a Nitrosamine Impurity Testing Company in the United States
FDA has made it mandatory for all ANDA and NDA applicants to:
- Conduct a risk assessment for the presence of nitrosamines.
- Submit analytical method validation and testing data for high-risk APIs and formulations.
- Include confirmatory test results for known nitrosamine impurities.
Only a dedicated Nitrosamine Impurity Testing Company in the United States with a deep understanding of FDA’s current thinking can ensure complete and compliant submissions.
Explore our regulatory compliance services: ResolveMass Nitrosamine Testing.
Core Services Offered by a Nitrosamine Impurity Testing Company in the United States
At a minimum, your chosen CRO should provide:
1. Risk-Based Assessment Consultation
ResolveMass provides science-driven nitrosamine risk assessments based on formulation, process chemistry, and supplier qualification.
2. Targeted Analytical Testing
- LC-MS/MS and GC-MS for NDMA, NDEA, NMBA, and more
- HRMS for ultra-trace level detection
See how we approach detection: Nitrosamine Analytical Capabilities.
3. Confirmatory Testing of Drug Products and APIs
Accurate, validated methods to quantify trace levels of known nitrosamines.
4. NDSRI Impurity Synthesis and Testing
ResolveMass offers custom synthesis of nitrosamine impurities that may not be commercially available—a key step for ANDA/NDA compliance.
Learn more: NDSRI Synthesis Services.
5. Full ICH-Compliant Method Validation
Essential for regulatory acceptance, especially when submitting to the U.S. FDA. Our validation reports include accuracy, precision, linearity, and robustness.
6. Regulatory Documentation Support
ResolveMass prepares submission-ready data packages for inclusion in Module 3 of your ANDA or NDA.
Visit our documentation support page: Nitrosamine Analysis.
Advantages of Using a Nitrosamine Impurity Testing Company in the United States vs Offshore Labs
While offshore testing partners may offer low-cost solutions, they often lack regulatory alignment, validation documentation, or the ability to provide quick response during FDA audits.
A U.S.-based CRO like ResolveMass ensures:
- Time-zone aligned communication
- Rapid turnaround for critical projects
- Full traceability for raw data, SOPs, and instruments
- Local compliance insight tailored to FDA expectations
This makes working with a Nitrosamine Impurity Testing Company in the United States a strategic advantage.
When to Engage a Nitrosamine Impurity Testing Company in the United States
If you are:
- Filing a new ANDA/NDA
- Responding to a Complete Response Letter (CRL)
- Addressing a Drug Master File (DMF) amendment
- Conducting Annual Product Quality Reviews (APQRs)
…you should engage a qualified testing partner early to avoid regulatory bottlenecks.
Talk to our regulatory consultants for strategic alignment.
ResolveMass: A Leading Nitrosamine Impurity Testing Company in the United States
ResolveMass Laboratories supports clients across the U.S. with:
- Extensive analytical infrastructure
- Senior chemists and regulatory specialists with decades of experience
- Flexible engagement models
- Rapid turnaround times
- End-to-end project transparency
We’ve helped dozens of clients achieve successful ANDA and NDA approvals through our Nitrosamine Impurity Testing Services.
Final Thoughts: Choose a Reliable Nitrosamine Impurity Testing Company in the United States
As the U.S. regulatory landscape continues to tighten, working with a qualified Nitrosamine Impurity Testing Company in the United States is no longer optional. It’s a critical success factor in your regulatory submission strategy.
ResolveMass Laboratories combines deep scientific expertise, validated analytical methods, and regulatory support that pharmaceutical manufacturers can trust.
If you’re preparing an ANDA or NDA, or need to respond to nitrosamine-related regulatory requirements, we’re here to help.
📞 Contact ResolveMass Laboratories
📝 Request a Nitrosamine Testing Quote
🚀 Schedule a Consultation with Our CRO Team
ResolveMass Laboratories Inc.: Experience, Expertise, and Trust You Can Count On
ResolveMass Laboratories Inc. has established itself as a trusted name in the domain of nitrosamine testing services in United States and Canada. With over a decade of dedicated experience, we have completed hundreds of successful nitrosamine testing and risk assessment projects for both domestic and international clients. Our scientists PhD level scientists who has specialized experience in Mass Spectrometry and Nitrosamine Impurity chemistry.
We are one of the few Canadian CROs to offer a complete in-house nitrosamine testing solution—from risk assessment to confirmatory analysis, regulatory documentation, and expert consultation. We continually invest in cutting-edge technologies and method development, keeping pace with evolving regulations and industry demands. We also provide the custom synthesis service of rare nitrosamine Impurities which are not availalbe anywhere.
Our clients trust us because we not only deliver accurate results but also help them understand and resolve complex impurity challenges. Choose ResolveMass Laboratories for your transperant nitrosamine testing services in United States and Canada—where precision meets reliability.
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
