In 2025, Custom Nitrosamine Confirmatory Testing has become an essential component of regulatory compliance for pharmaceutical manufacturers. The industry has witnessed an uptick in regulatory alerts from agencies such as the FDA, EMA, and Health Canada, emphasizing the need for compound-specific nitrosamine impurity testing. If your drug product contains high-risk Active Pharmaceutical Ingredients (APIs), you must implement validated Custom Nitrosamine Confirmatory Testing to ensure patient safety and regulatory submission success.
ResolveMass Laboratories Inc. specializes in Custom Nitrosamine Confirmatory Testing and has supported numerous clients in meeting these evolving standards. Explore our full range of nitrosamine services here:
Why Custom Nitrosamine Confirmatory Testing Is Critical in 2025
Generic methods are no longer sufficient for detecting nitrosamines in many complex APIs. Regulatory bodies now expect sponsors to develop API-specific testing methods that detect both known and novel nitrosamines. Custom Nitrosamine Confirmatory Testing enables this by accounting for molecular structure, manufacturing processes, and formulation-specific factors.
At ResolveMass Laboratories, our custom assays are built to detect nitrosamines at sub-ppb levels using LC-MS/MS, GC-MS/MS, and HRMS platforms. We assist pharmaceutical manufacturers by developing and validating methods tailored to their API and dosage form.
Find detailed method development strategies here: https://resolvemass.ca/nitrosamine-analysis/
1. Valsartan
Valsartan, an angiotensin II receptor blocker, continues to be under scrutiny for NDMA contamination due to its tetrazole ring synthesis. Since the initial recalls in 2018, regulatory agencies now require ongoing Custom Nitrosamine Confirmatory Testing to detect:
- NDMA
- NDEA
- EIPNA
ResolveMass Laboratories offers validated methods for valsartan and related sartans. Our protocols are designed for high-throughput batch release and stability studies.
Partner with us for Valsartan testing: https://resolvemass.ca/nitrosamine-analysis/
2. Metformin
Metformin, a widely prescribed diabetes medication, was flagged for NDMA presence in extended-release formulations. Custom Nitrosamine Confirmatory Testing is required to assess the impact of excipients, storage conditions, and packaging materials.
Our lab has extensive experience analyzing:
- API-excipient interactions
- Heat-induced nitrosamine formation
- Nitrosation pathways under stress conditions
Explore our confirmatory testing workflow: https://resolvemass.ca/nitrosamine-analysis/
3. Rifampin
Rifampin, used in tuberculosis treatment, is another API under regulatory watch due to the presence of 1-methyl-4-nitrosopiperazine (MNP). This API requires Custom Nitrosamine Confirmatory Testing with extremely low limits of detection.
ResolveMass has developed:
- LC-MS/MS quantification methods for MNP
- Stability-indicating methods
- Matrix-sensitive analysis for oral and injectable forms
Need custom testing support for Rifampin? https://resolvemass.ca/nitrosamine-analysis/
4. Losartan
Losartan, another sartan-class antihypertensive, often shares synthetic routes similar to Valsartan. However, the formation of unique nitrosamine impurities requires API-specific confirmatory testing.
Our lab evaluates:
- Synthetic impurity profiles
- NDSRI-specific risks
- Custom internal standards
We provide regulatory-ready data packages: https://resolvemass.ca/nitrosamine-analysis/
5. Sitagliptin
Sitagliptin, a DPP-4 inhibitor used in type 2 diabetes, was recently identified as potentially generating nitrosamine impurities under certain conditions. While not previously a high-risk API, evolving data has prompted regulatory interest.
Custom Nitrosamine Confirmatory Testing for Sitagliptin includes:
- Forced degradation studies
- Identification of novel nitrosamines
- Risk evaluation of formulation variables
Secure your sitagliptin project with ResolveMass: https://resolvemass.ca/nitrosamine-analysis/
What Makes ResolveMass Your Trusted Partner for Custom Nitrosamine Confirmatory Testing
- Decades of analytical chemistry expertise
- ICH-compliant method validation
- Advanced LC-MS/MS, GC-MS/MS, and HRMS instrumentation
- Custom synthesis of reference standards
- Rapid turnaround for NDA, ANDA, and post-market submissions
Each API requires a unique confirmatory strategy. ResolveMass delivers customized testing workflows backed by regulatory knowledge and robust analytical validation.
Start your consultation: https://resolvemass.ca/nitrosamine-analysis/
Conclusion: Choose Expert Custom Nitrosamine Confirmatory Testing in 2025
With regulatory expectations increasing, Custom Nitrosamine Confirmatory Testing is no longer optional. APIs like Valsartan, Metformin, Rifampin, Losartan, and Sitagliptin require dedicated impurity analysis to ensure regulatory acceptance and patient safety. ResolveMass Laboratories offers tailored solutions for Custom Nitrosamine Confirmatory Testing that meet global compliance standards and accelerate drug development timelines.
Choose ResolveMass for accurate, compliant, and timely testing solutions.
Explore full services: https://resolvemass.ca/nitrosamine-analysis/
For quotes, consultations, or regulatory submission support, get in touch:
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.
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📩 Contact our expert team
📞 Request a quote for method development
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🧪 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
