In today’s highly regulated pharmaceutical environment, manufacturers are under pressure to ensure that every product batch is free of harmful contaminants. One of the most urgent and scrutinized threats in recent years has been nitrosamine impurities—carcinogenic compounds that can form during the manufacturing process. Engaging a specialized nitrosamine impurity analysis lab is now essential for regulatory compliance and patient safety.
At ResolveMass Laboratories Inc., we offer end-to-end nitrosamine impurity testing services trusted by drug developers and manufacturers across Canada and the United States.
Explore our nitrosamine impurity testing services
The Growing Importance of Nitrosamine Testing in Pharmaceuticals
Global health authorities like the FDA, Health Canada, and EMA have issued strict mandates for the control and testing of nitrosamine impurities. Since the detection of NDMA and NDEA in blood pressure medications, there has been an increased focus on evaluating the risk of nitrosamine formation across all drug classes.
Only a qualified nitrosamine impurity analysis lab can offer the technical infrastructure and regulatory alignment needed to ensure complete compliance and public safety.
👉 Understand nitrosamine regulatory guidance
What Makes a Specialized Nitrosamine Impurity Analysis Lab Essential?
1. Expertise in Nitrosamine Chemistry
Detecting nitrosamine impurities is not simple. It requires deep knowledge of:
- Chemical synthesis pathways
- Nitrosamine formation mechanisms
- Matrix interactions
- Analytical interferences
ResolveMass Laboratories is staffed by analytical chemists and toxicologists with extensive experience in impurity profiling. Our nitrosamine impurity analysis lab has developed validated methods for complex compounds, including volatile and non-volatile nitrosamines, and newly emerging NDSRIs.
Learn about our technical capabilities
2. Advanced Instrumentation and Methodology
Our lab is equipped with state-of-the-art LC-MS/MS and GC-MS/MS systems, enabling ultra-trace level detection of nitrosamines down to sub-ppb levels. Every method developed in our nitrosamine impurity analysis lab adheres to:
- ICH Q2(R1) method validation guidelines
- GLP-compliant documentation practices
- ISO/IEC 17025-aligned precision and accuracy checks
3. End-to-End Nitrosamine Testing Services at Nitrosamine Impurity Analysis Lab
A complete nitrosamine impurity analysis lab must offer more than just testing. At ResolveMass, we support every phase of your regulatory journey with:
✔ Risk Assessment Report
- Evaluate synthesis pathways, raw materials, and packaging
- Identify high-risk formation routes of nitrosamines
- Deliver comprehensive, submission-ready reports
👉 Explore our Nitrosamine Risk Assessment Service
✔ Method Development and Validation
- Custom method development using LC-MS/MS and GC-MS/MS
- Matrix-specific validation parameters
- Long-term and accelerated stability testing methods
👉 Request a Nitrosamine Risk Assessment Template
✔ Confirmatory and Batch Testing at Nitrosamine Impurity Analysis Lab
- Screening of common nitrosamines and custom NDSRIs
- Compliance testing for drug substances and finished products
- Batch release support and submission documentation
👉 Detailed breakdown of our services
Common Nitrosamines We Analyze
Our nitrosamine impurity analysis lab tests for a wide spectrum of nitrosamine compounds, including:
- NDMA (N-Nitrosodimethylamine)
- NDEA (N-Nitrosodiethylamine)
- NMBA (N-Nitroso-N-methyl-4-aminobutyric acid)
- NEIPA (N-Nitrosoethylisopropylamine)
- NDIPA (N-Nitrosodiisopropylamine)
- NDSRIs – Custom synthesized drug substance-related impurities
Our lab also monitors for newly identified nitrosamines as flagged by regulators.
Explore our nitrosamine impurity detection list
Regulatory Risk of Not Choosing a Specialized Nitrosamine Impurity Analysis Lab
Choosing a non-specialized or generic lab can introduce unacceptable risks, such as:
- False negatives due to poor method sensitivity
- Incomplete impurity profiling
- Regulatory rejection of submission data
- Product recalls and brand damage
ResolveMass has a proven track record of assisting clients in navigating Health Canada, FDA, and EMA regulatory requirements with confidence. We stand out as a dedicated nitrosamine impurity analysis lab focused on quality, speed, and scientific depth.
Partner with ResolveMass for full regulatory alignment
Real-World Applications Across Pharma Projects
ResolveMass supports pharmaceutical projects across:
- Generic and branded drug developers
- API manufacturers
- Finished dosage manufacturers
- Contract manufacturing organizations (CMOs)
Whether you need screening during development or confirmatory testing during stability studies, our nitrosamine impurity analysis lab has a solution ready.
Find the right testing plan for your needs
Why Choose ResolveMass as Your Nitrosamine Impurity Analysis Lab?
We combine scientific precision, regulatory fluency, and customer service to provide:
- Fast turnarounds (5–10 business days)
- Submission-ready data
- Full technical support from project start to finish
- Transparent, client-first communication
As a recognized nitrosamine impurity analysis lab, ResolveMass is the trusted choice for pharmaceutical companies in Canada and across North America.
Start your nitrosamine testing project
🧪 ResolveMass Laboratories Inc.: The Authority in Mass Spectrometry-Based Testing Services Across the United States and Canada
With a legacy of scientific precision and regulatory excellence, ResolveMass Laboratories Inc. stands as the leading authority in mass spectrometry-based testing services for pharmaceutical and life science industries in Canada and the United States. Our lab is equipped with advanced LC-MS/MS and GC-MS/MS platforms, operated by a multidisciplinary team of analytical chemists, toxicologists, and regulatory scientists.
We specialize in ultra-trace level quantification of complex impurities—including nitrosamines, genotoxic impurities, and elemental contaminants—delivering GLP-compliant, submission-ready data trusted by top-tier pharmaceutical developers, API manufacturers, and global CMOs.
From early-stage R&D to post-marketing surveillance, ResolveMass sets the benchmark for precision, speed, and regulatory alignment in analytical testing across North America.
Frequently Asked Questions
What if I only need confirmatory testing?
We offer modular services — clients can engage us for just confirmatory testing, full risk assessments, or a full-spectrum testing package.
Can you test for custom NDSRIs?
Yes. We are one of the few nitrosamine impurity analysis labs that offer custom NDSRI synthesis and targeted analysis.
Do you support regulatory filings?
Absolutely. All of our reports are formatted to meet submission standards for Health Canada, FDA, and EMA filings.
Final Thoughts: Choose the Right Nitrosamine Impurity Analysis Lab
In a world of increasing scrutiny and zero tolerance for risk, choosing a qualified nitrosamine impurity analysis lab is not a luxury — it’s a regulatory necessity. From early-stage development to commercial batch testing, ResolveMass Laboratories provides unmatched expertise, precision, and regulatory alignment for nitrosamine impurity testing.
Let’s ensure your products are safe, compliant, and market-ready.
Contact ResolveMass Laboratories Today
- Contact our scientific team
- Request a quote
- Book your initial consultation
- Discuss your testing timeline
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
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