As global pharmaceutical regulations tighten around nitrosamine impurities, standard one-size-fits-all testing methods are no longer enough. Drug products with complex matrices, novel synthetic pathways, and unique drug substance-related impurities (NDSRIs) require tailored approaches. That’s where custom method development for nitrosamine testing becomes not just helpful—but absolutely essential.
At ResolveMass Laboratories Inc., we specialize in designing and validating bespoke analytical methods that ensure accuracy, sensitivity, and full regulatory compliance.
Explore our nitrosamine analysis services
Why Custom Method Development for Nitrosamine Testing Matters
Nitrosamines are known carcinogens, and the presence of these impurities—even in trace amounts—can lead to regulatory actions, product recalls, and delays in drug approvals. Traditional testing methods may work for simple APIs, but modern pharmaceutical formulations demand specificity. Custom method development for nitrosamine testing ensures the detection of target impurities in even the most challenging matrices.
See our nitrosamine testing expertise
The ResolveMass Advantage: Expertise Meets Innovation
Unmatched Experience in Custom Method Development
At ResolveMass Laboratories, our team has decades of combined experience in:
- Analytical chemistry
- LC-MS/MS and GC-MS/MS method design
- Genotoxic impurity profiling
- Regulatory submission support
Each custom method is built from the ground up, considering compound-specific behavior, excipient interference, sample preparation complexity, and required sensitivity.
When Do You Need Custom Method Development for Nitrosamine Testing?
1. Testing Novel NDSRIs
Many nitrosamine impurities are NDSRIs—nitrosamines derived from drug substance-specific degradation or synthetic routes. These impurities often cannot be detected using compendial methods and require custom synthesis of reference standards followed by tailored method development.
2. Complex Drug Matrices
Formulations like:
- Modified-release tablets
- Combination products
- Biological drug substances
can create matrix interferences. Custom method development for nitrosamine testing allows the optimization of extraction, separation, and detection tailored to your product.
3. Regulatory Rejections of Generic Methods
The FDA and Health Canada increasingly reject data generated from off-the-shelf test methods. Custom-developed and validated methods demonstrate a higher level of scientific diligence and regulatory alignment.
Stay compliant with our custom methods
Core Components of Custom Method Development for Nitrosamine Testing
✔ Analytical Method Design
- Selection of target nitrosamines (e.g., NDMA, NDEA, NMBA, NDBA, NEIPA, NDIPA, and custom NDSRIs)
- Mass spectrometry conditions optimized for sensitivity
- Sample prep tailored to drug form and excipients
✔ Method Validation (ICH Q2 Guidelines)
- Linearity, accuracy, precision, LOQ/LOD
- Specificity and robustness
- Matrix recovery and carryover studies
✔ Stability-Indicating Testing
- Long-term and accelerated testing to detect nitrosamine formation over time
- Method revalidation under stress conditions
Learn more about our method validation services
Technologies We Use for Custom Method Development
Our custom method development for nitrosamine testing is powered by:
- LC-MS/MS (Triple Quadrupole Mass Spectrometry) for ultra-trace detection
- GC-MS/MS for volatile nitrosamines
- Isotope dilution techniques for improved accuracy
- High-resolution mass spectrometry when needed
Our lab is equipped with best-in-class instrumentation, ensuring industry-leading sensitivity, reproducibility, and reliability.
Regulatory Compliance and Submission-Ready Data
Each method developed at ResolveMass follows:
- ICH Q2(R1) validation framework
- Documentation aligned with FDA, EMA, and Health Canada expectations
- Full GLP-compliant protocols and reports
We don’t just test—we equip you with everything needed to defend your data during audits and submissions.
Prepare your regulatory submission with confidence
A Look at Real-World Applications
Our custom method development for nitrosamine testing supports:
- ANDA, NDA, and DIN submissions
- Drug product shelf-life evaluations
- In-process testing of APIs and intermediates
- Extractables and leachables studies where nitrosamines are a risk
- Quality control for commercial production
Whether you’re in early R&D or late-stage manufacturing, ResolveMass is your partner for precise and compliant nitrosamine testing.
Start your custom project today
Why Pharma Companies Across North America Trust ResolveMass
ResolveMass Laboratories Inc. is recognized across Canada and the United States as a leading authority in nitrosamine impurity testing. Here’s why:
- Expert team of method developers and mass spectrometrists
- Industry-compliant GLP and ISO practices
- Ultra-sensitive detection thresholds
- Personalized support and fast turnaround times
- Proven regulatory track record
See why we’re trusted by leading pharma companies
Frequently Asked Questions
Can you synthesize reference standards for NDSRIs?
Yes. We can custom-synthesize drug-specific nitrosamines to enable accurate testing.
How long does custom method development take?
Typically, 2–4 weeks, depending on complexity. We also offer expedited service.
Do you offer method validation?
Absolutely. All custom methods can be validated per ICH Q2 and tailored to your product’s lifecycle needs.
Final Thoughts: Custom Method Development for Nitrosamine Testing Is Not Optional—It’s Essential
As regulatory demands rise and formulations become more complex, custom method development for nitrosamine testing is now a critical part of any pharmaceutical testing program. At ResolveMass Laboratories, we combine experience, advanced instrumentation, and regulatory insight to deliver robust and compliant solutions tailored to your exact needs.
Let us help you stay ahead of the curve—and confidently bring safe, compliant products to market.
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
