In today’s pharmaceutical landscape, regulatory scrutiny around nitrosamine impurities continues to intensify. For manufacturers of finished dosage forms, Nitrosamine Testing for Finished Drug Products is not just a regulatory expectation—it is a critical quality safeguard. At ResolveMass Laboratories Inc., we offer end-to-end nitrosamine testing solutions designed specifically for finished pharmaceutical products, helping companies ensure compliance, mitigate risks, and protect patients.
Discover our full range of nitrosamine testing capabilities
Why is Nitrosamine Testing for Finished Drug Products Critical?
Nitrosamines are classified as probable human carcinogens by the International Agency for Research on Cancer (IARC). These compounds can form during the manufacturing, packaging, or storage of drug products. Since 2018, various recalls and regulatory actions have brought nitrosamines into the spotlight, prompting global health agencies to demand rigorous testing.
Nitrosamine Testing for Finished Drug Products ensures that the final product delivered to patients is free from harmful levels of these impurities, complying with the latest FDA, EMA, and Health Canada guidelines.
When is Nitrosamine Testing for Finished Drug Products Required?
1. Post-Risk Assessment Confirmation for Nitrosamine Testing for Finished Drug Products
After performing a risk assessment of your drug product’s formulation and manufacturing process, confirmatory testing is essential if a potential risk of nitrosamine formation is identified.
2. Regulatory Submissions and Audits
Most new and existing drug applications now require documentation showing compliance with nitrosamine limits. Having Nitrosamine Testing for Finished Drug Products data on hand ensures readiness for regulatory audits.
Learn how we support your submissions
3. Ongoing Stability Studies for Nitrosamine Testing for Finished Drug Products
Nitrosamines can form over time due to environmental conditions. Integrating Nitrosamine Analysis for Finished Drug Products in stability protocols helps detect delayed impurity formation.
4. Changes in Manufacturing Site or Process
Any modification to the manufacturing process, formulation, or API supplier can impact nitrosamine levels. Confirmatory testing post-change is critical to maintaining product safety.
Start testing after your next process change
5. Market Complaints or Regulatory Alerts
If any red flags are raised post-marketing—either by customers or regulators—Nitrosamine Analysis for Finished Drug Products can quickly verify the presence and extent of contamination.
Our Expertise in Nitrosamine Testing for Finished Drug Products
Advanced Analytical Technologies
At ResolveMass Laboratories, we use ultra-sensitive instruments like LC-MS/MS, GC-MS, and high-resolution Orbitrap to detect nitrosamines at parts-per-billion (ppb) levels. Our validated methods ensure precision and reliability.
Dedicated Team for Nitrosamine Testing for Finished Drug Products
Our scientists bring years of experience in pharmaceutical impurity profiling, with specific expertise in Nitrosamine Analysis for Finished Drug Products across all major dosage forms, including tablets, capsules, injectables, and more.
Meet our nitrosamine analysis experts
Regulatory-Aligned Methodologies
All our testing protocols follow international regulatory frameworks, including ICH M7(R1), FDA guidelines, and EMA nitrosamine guidance. We stay ahead of evolving requirements to keep your product fully compliant.
Dosage Forms We Support in Nitrosamine Testing for Finished Drug Products
Tablets and Capsules
We perform targeted extraction and analysis methods tailored for solid oral dosage forms to ensure accurate nitrosamine quantification.
Liquid Injectables
Our methods ensure no interference from excipients or solvents, providing a clear view of any nitrosamine presence in injectable products.
Ointments and Topicals
Even semisolid formulations can harbor nitrosamines. We offer validated protocols for such complex matrices.
Find out more about our dosage form testing capabilities
Which Nitrosamines Do We Test For Nitrosamine Testing for Finished Drug Products ?
We routinely test for the following nitrosamines:
- NDMA (N-Nitrosodimethylamine)
- NDEA (N-Nitrosodiethylamine)
- NMBA (N-Nitroso-N-methyl-4-aminobutyric acid)
- NDBA (N-Nitrosodibutylamine)
- NIPEA (N-Nitrosoisopropylethylamine)
- NMPA (N-Nitrosomethylphenylamine)
- NEIPA (N-Nitrosoethylisopropylamine)
- NDSRIs (Nitrosamine Drug Substance Related Impurities)
Explore our comprehensive nitrosamine panel
Key Benefits of ResolveMass Nitrosamine Testing for Finished Drug Products
- Regulatory Readiness: Full compliance with FDA, EMA, and Health Canada standards
- Customized Testing: Tailored protocols for your unique product matrix
- Rapid Turnaround: Reliable results delivered within tight timelines
- Confidential Reporting: Secure and detailed documentation
- Actionable Insights: Guidance on mitigation strategies if nitrosamines are detected
Incorporating Testing Into Your Quality System
Incorporating Nitrosamine Analysis for Finished Drug Products into your ongoing quality assurance programs is a proactive step toward long-term compliance and product integrity. Testing should not be limited to one-off evaluations but considered a regular part of your QA process.
Best Practices Include:
- Periodic re-testing of retained samples
- Inclusion in annual product review
- Integration into release testing when applicable
The ResolveMass Advantage
Experience
With years of analytical expertise and successful partnerships with global pharmaceutical companies, ResolveMass is a trusted leader in nitrosamine testing.
Expertise
Our staff includes chemists, toxicologists, and QA professionals with specialized training in Nitrosamine Testing
Authoritativeness
We’ve been a key testing partner in numerous Health Canada and FDA compliance projects, providing expert data for critical regulatory filings.
Trustworthiness
Our transparent methods, secure data handling, and high accuracy make us the laboratory partner of choice.
Why ResolveMass is a name you can trust
Conclusion
Ensuring patient safety and product integrity is the cornerstone of responsible pharmaceutical manufacturing. Through high-precision Nitrosamine Testing for Finished Drug Products, ResolveMass Laboratories Inc. enables your company to meet regulatory demands with confidence and transparency.
Don’t wait for regulatory intervention—take proactive steps today with our expert services.
Partner with ResolveMass now or get in touch to begin your testing program.
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
