The presence of nitrosamine impurities in pharmaceutical products has raised significant regulatory concerns globally, pushing the need for reliable, science-driven solutions. At ResolveMass Laboratories Inc., we pride ourselves on being a full-service Nitrosamine Impurity Analysis Company, offering comprehensive end-to-end solutions—from initial risk assessments to confirmatory testing and regulatory compliance.
Why Choose a Specialized Nitrosamine Impurity Analysis Company?
Nitrosamines are probable human carcinogens, and their detection at even trace levels in drug substances and products has led to widespread recalls and regulatory action. Working with an expert Nitrosamine Impurity Analysis Company ensures your pharmaceutical development pipeline stays compliant with stringent regulatory requirements set by Health Canada, the US FDA, and EMA.
ResolveMass Laboratories offers a deeply integrated approach to nitrosamine analysis, bringing together advanced analytical instrumentation, regulatory expertise, and validated workflows tailored for API, excipient, and finished product testing.
Learn more about our full range of Nitrosamine Analytical Testing Services.
Step 1 – Nitrosamine Risk Assessment by a Qualified Nitrosamine Impurity Analysis Company
A foundational step in any nitrosamine control strategy is the risk assessment. As a premier Nitrosamine Impurity Analysis Company, ResolveMass applies structured, science-backed risk evaluation methods compliant with ICH M7 and Health Canada guidance.
Our process involves:
- Comprehensive evaluation of API synthesis pathways
- Raw material and excipient risk profiling
- Identification of potential nitrosating agents and vulnerable amine sources
- Review of manufacturing processes for contamination risk
This risk assessment is critical in prioritizing which materials require in-depth testing and mitigation.
For detailed methodologies, visit our Nitrosamine Testing Overview Page.
Step 2 – Laboratory Screening and Method Development by Experts
Once a risk is identified, our laboratory offers targeted and untargeted screening using GC-MS, LC-MS/MS, and high-resolution mass spectrometry (HRMS). As a trusted Nitrosamine Impurity Analysis Company, we ensure our methods are:
- Sensitive to sub-ppb levels
- Validated per ICH Q2(R1)
- Designed for a wide range of nitrosamine species, including NDSRIs
We develop custom methods for complex matrices including biologics, peptides, and controlled-release formulations. These validated workflows are ready to meet Health Canada and US FDA inspection criteria.
Read about our approach to Nitrosamine Confirmatory Testing.
Step 3 – Confirmatory Testing and Structural Elucidation
ResolveMass sets the gold standard in confirmatory testing. We are a Nitrosamine Impurity Analysis Company equipped to not only quantify nitrosamines but also identify unknown NDSRIs via:
- HRMS and MSn structural analysis
- Synthesis of reference standards
- Isotope dilution techniques
- Analytical purity profiling
We specialize in distinguishing between common nitrosamines (e.g., NDMA, NDEA) and emerging complex NDSRIs that require customized evaluation strategies.
Visit our Advanced Analytical Services to see how we support your NDA or ANDA filing.
Full-Service Workflow Backed by Regulatory Knowledge
What sets ResolveMass apart as a Nitrosamine Impurity Analysis Company is our in-house regulatory team. We support clients from early-stage R&D through regulatory submissions, providing:
- Risk documentation aligned with ICH and EMA frameworks
- Study protocols and validation reports for submission
- Responses to agency deficiency letters and CAPA planning
Our team has extensive experience supporting filings in Canada, the US, and Europe.
Check out our regulatory consulting services.
Expertise in NDSRI Synthesis and Qualification
Many Nitrosamine Impurity Analysis Companies lack the capability to synthesize and characterize NDSRIs, but ResolveMass offers:
- Custom synthesis of nitrosamine impurities and reference standards
- Purity confirmation using NMR and HPLC
- Toxicological data interpretation and SAR modeling
- Support for TTC and AI limit justifications
Explore our advanced support for NDSRI impurity analysis and synthesis.
Quality Control and GMP-Compliant Reporting
As a GMP-compliant Nitrosamine Impurity Analysis Company, ResolveMass ensures:
- Data integrity with full audit trails
- Instrument calibration traceable to international standards
- Electronic reporting aligned with 21 CFR Part 11
- Chain-of-custody assurance for every sample
Clients receive detailed reports with chromatograms, calibration curves, recovery rates, and LOD/LOQ data.
Industries We Serve as a Nitrosamine Impurity Analysis Company
Our solutions are tailored for:
- Pharmaceutical manufacturers
- API suppliers and CMOs
- Regulatory consultants
- Biotech startups and virtual pharma
Whether you are responding to a regulatory notice or proactively preparing your dossier, we provide scalable solutions.
Global Clients Trust ResolveMass as Their Nitrosamine Impurity Analysis Company
ResolveMass is not just a lab—we’re your strategic partner. With clients across Canada, the United States, and Europe, our lab has earned a reputation for:
- Unmatched technical depth
- Fast turnaround times (typically 2–3 weeks)
- Transparent pricing and responsive project management
Discover why industry leaders choose us for Nitrosamine Testing Solutions.
Conclusion – The Trusted Nitrosamine Impurity Analysis Company for End-to-End Solutions
From risk assessment to regulatory-ready confirmatory testing, ResolveMass Laboratories Inc. offers a complete service suite as your go-to Nitrosamine Impurity Analysis Company. We combine scientific excellence with regulatory insight, ensuring your pharmaceutical products meet the highest safety and compliance standards.
Connect with us today to start your project. We’re ready to help you move from uncertainty to clarity with confidence.
Contact ResolveMass – Get Started with a Leading Nitrosamine Impurity Analysis Company
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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 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 possess advanced degrees in analytical chemistry and pharmaceutical sciences, bringing a wealth of expertise to every project.
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.
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 nitrosamine testing services in 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
