In today’s regulated pharmaceutical environment, Nitrosamine Method Development is not just a compliance requirement—it’s a crucial step in accelerating speed-to-market. For companies preparing NDA (New Drug Application) or ANDA (Abbreviated New Drug Application) submissions, delays in nitrosamine impurity testing can result in costly launch setbacks. ResolveMass Laboratories Inc. brings decades of analytical and regulatory expertise to provide rapid Nitrosamine Method Development, ensuring both speed and compliance.
Explore our comprehensive services here: https://resolvemass.ca/nitrosamine-analysis/
Why Nitrosamine Method Development Matters for NDA/ANDA
Regulatory agencies including the FDA, EMA, and Health Canada mandate robust Nitrosamine Method Development to detect trace levels of carcinogenic nitrosamine impurities. Since 2018, multiple drug recalls have heightened the scrutiny around NDMA, NDEA, and other nitrosamines. For companies preparing submissions, method readiness is a key milestone.
ResolveMass Laboratories specializes in Nitrosamine Method Development tailored to tight timelines and precise regulatory standards. Learn more about our validated workflows: https://resolvemass.ca/nitrosamine-analysis/
Step-by-Step: Our Nitrosamine Method Development Process
1. Regulatory Risk Review and API Assessment
Before initiating method development, we conduct a detailed risk analysis based on the API structure, synthesis route, and excipients. This step identifies potential N-nitrosamine risks and sets the foundation for a focused Nitrosamine Method Development strategy.
2. Custom Analytical Method Design
Using LC-MS/MS or GC-MS/MS platforms, our scientists design targeted detection methods that are sensitive, selective, and specific. Each Nitrosamine Method Development plan includes:
- Identification of target nitrosamines (NDMA, NDEA, NMBA, etc.)
- Internal standard selection
- Matrix-specific considerations
See our capabilities in action: https://resolvemass.ca/nitrosamine-analysis/
Using LC-MS/MS or GC-MS/MS platforms, our scientists design targeted detection methods that are sensitive, selective, and specific. Each Nitrosamine Method Development plan includes:
- Identification of target nitrosamines (NDMA, NDEA, NMBA, etc.)
- Internal standard selection
- Matrix-specific considerations
Technical Approach Using LC-MS/MS:
- Ionization Mode: Positive electrospray ionization (ESI+) is typically used due to the polar nature of nitrosamines.
- MRM Transitions: We develop multiple reaction monitoring (MRM) transitions optimized for each nitrosamine. For example, NDMA might use precursor ion m/z 75 → product ion m/z 43.
- Chromatographic Separation: Reverse-phase columns (e.g., C18, 100 mm × 2.1 mm, 1.7 µm particle size) are employed with gradient elution using formic acid in water and acetonitrile.
- Retention Time Stability: Each analyte is retained within a defined window to avoid matrix interference and ensure reproducibility.
- LOD/LOQ Optimization: Our method achieves detection limits in the low ppb or sub-ppb range, compliant with regulatory expectations.
- Internal Standards: Isotope-labeled standards (e.g., NDMA-d6) are used for quantification, improving method accuracy and correcting for matrix effects.
See our capabilities in action: https://resolvemass.ca/nitrosamine-analysis/
3. Method Validation in Compliance with ICH Guidelines
All methods are validated per ICH Q2 (R1) for:
- Accuracy and precision
- Linearity and range
- Limit of detection (LOD)
- Limit of quantification (LOQ)
- Robustness (e.g., variations in mobile phase, column temperature, flow rate)
- Specificity (ensuring no interference from matrix components or co-eluting peaks)
This validation process ensures your Nitrosamine Method Development data is ready for direct submission to regulatory agencies.
4. Rapid Turnaround and Real-Time Client Updates
We understand that NDA/ANDA timelines are tight. Our lab prioritizes Nitrosamine Method Development requests for regulatory filings, delivering:
- Initial method development in as little as 5–10 business days
- Ongoing communication throughout the project
- Detailed method reports and validation packages
Need a quote? Start here: https://resolvemass.ca/nitrosamine-analysis/
The ResolveMass Advantage in Nitrosamine Method Development
Extensive Regulatory Experience
Our team has supported dozens of NDA/ANDA submissions with comprehensive Nitrosamine Method Development reports. We understand the nuances of regional guidelines, from FDA’s latest guidance to EMA’s Sartan limits.
State-of-the-Art Instrumentation
ResolveMass is equipped with:
- Triple quadrupole LC-MS/MS
- Headspace GC-MS/MS
- High-resolution mass spectrometry (HRMS)
These instruments enable ultra-trace quantification and high-throughput method development.
Turnkey Regulatory Submission Support
Once your Nitrosamine Method Development is complete, we help compile the data for submission packages. Our deliverables include:
- Method validation reports
- Instrument setup documentation
- SOPs (Standard Operating Procedures)
- Risk assessment statements
For details, visit: https://resolvemass.ca/nitrosamine-analysis/
Nitrosamine Method Development for NDSRIs
NDSRIs (Nitrosamine Drug Substance Related Impurities) require special consideration due to their compound-specific nature. ResolveMass supports:
- Synthesis of custom reference standards
- Structure-based risk prediction
- Custom Nitrosamine Method Development for novel impurities
This is especially important for new chemical entities (NCEs) and complex generic drugs.
What to Look for in a Nitrosamine Method Development Partner
Not all labs are equipped to handle regulatory-level Nitrosamine Method Development. Look for partners who offer:
- Demonstrated regulatory experience
- In-house analytical chemistry experts
- Transparent timelines and QC documentation
- End-to-end project support
At ResolveMass, we fulfill all of the above with full GMP compliance.
Partner with us: https://resolvemass.ca/nitrosamine-analysis/
Frequently Asked Questions About Nitrosamine Method Development
Q: How quickly can method development be completed?
A: We typically complete initial Nitrosamine Method Development within 10 business days, depending on complexity.
Q: Can ResolveMass develop methods for unknown nitrosamines?
A: Yes. We offer both targeted and non-targeted screening for known and novel nitrosamines, including NDSRIs.
Q: Will your method meet FDA/EMA acceptance criteria?
A: Yes. All methods follow ICH and agency-specific guidelines to ensure global compliance.
Q: Can I request a sample validation report?
A: Absolutely. Reach out via our Contact Page to request a sample.
Conclusion: Accelerate Submission with Expert Nitrosamine Method Development
Your NDA or ANDA timeline depends on how quickly and reliably your analytical data can be produced. At ResolveMass Laboratories Inc., we combine scientific expertise, regulatory experience, and advanced instrumentation to deliver Nitrosamine Method Development that accelerates your submission without compromising on compliance.
Don’t let analytical delays hold up your market entry—partner with a lab that delivers.
Explore our full range of services: https://resolvemass.ca/nitrosamine-analysis/
For custom quotes, validation reports, or submission support, reach out to our 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 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
