As regulatory demands continue to intensify across North America and globally, pharmaceutical manufacturers are under increasing pressure to ensure their products meet stringent impurity thresholds — especially when it comes to nitrosamines. Engaging a specialized nitrosamine analysis laboratory is now a critical step in the drug development and lifecycle management process. At ResolveMass Laboratories Inc., we offer advanced, regulation-aligned nitrosamine testing solutions trusted by leading pharmaceutical companies across Canada and the United States.
Why Nitrosamine Testing Is a Regulatory Imperative
Nitrosamines such as NDMA, NDEA, NMBA, and emerging NDSRIs are classified as probable human carcinogens. Regulatory authorities including Health Canada, the FDA, and EMA have issued strict guidance for their detection and control. Drug product recalls related to nitrosamines have created widespread regulatory risk — and the only way to mitigate that is by working with a capable nitrosamine analysis laboratory equipped with validated methods and a deep understanding of global expectations.
At ResolveMass, our comprehensive services include:
- Risk assessments aligned with ICH M7(R1)
- Method development and validation
- Confirmatory testing and impurity profiling
- Ongoing stability and surveillance testing
- Submission-ready data packages
Learn more about our full nitrosamine services
What Sets a Nitrosamine Analysis Laboratory Apart?
Not all laboratories are created equal — especially when regulatory compliance and product safety are at stake. Here’s what leading pharmaceutical companies look for when choosing a nitrosamine analysis laboratory:
1. Deep Analytical Experience of Nitrosamine Analysis Laboratory
ResolveMass brings over a decade of experience in impurity profiling and genotoxic impurity analysis. Our analytical chemists have led projects for nitrosamine detection across multiple drug classes, including sartans, ranitidine, metformin, and rifampin. This hands-on expertise allows us to navigate complex matrices and develop precise quantitation methods.
View our experience in nitrosamine testing
2. Advanced Instrumentation and Ultra-Low Detection Capabilities at Nitrosamine Analysis Laboratory
Detecting nitrosamines at parts-per-billion (ppb) or even parts-per-trillion levels requires advanced instrumentation. Our nitrosamine analysis laboratory is equipped with:
- LC-MS/MS and GC-MS/MS platforms
- Fully validated methods with sub-ppb limits of detection
- Robust quantification workflows for both volatile and non-volatile nitrosamines
Explore our testing capabilities
3. Technical Rigor in Method Development and Validation
Each project at ResolveMass begins with a thorough understanding of the drug substance and formulation matrix. Our scientists develop custom methods where compendial protocols don’t exist, followed by rigorous validation to meet ICH and regulatory expectations.
Three Core Services Offered by a Nitrosamine Analysis Laboratory
At ResolveMass, our nitrosamine testing workflow is divided into three critical stages that align with regulatory expectations:
1. Risk Assessment Report
Before testing begins, a structured nitrosamine risk assessment is essential. Our scientific team evaluates your API, formulation, manufacturing process, and packaging components to determine potential nitrosamine formation routes.
As a trusted nitrosamine analysis laboratory, ResolveMass delivers comprehensive reports that include:
- Root-cause analysis for potential nitrosamine generation
- Evaluation against ICH M7(R1), EMA, and Health Canada frameworks
- Recommendations for analytical strategies and control mechanisms
This step forms the foundation for regulatory engagement and testing scope.
2. Method Development and Validation
Where compendial methods are unavailable or unsuitable, our laboratory develops and validates custom analytical methods in compliance with ICH Q2(R1).
Our nitrosamine analysis laboratory capabilities include:
- LC-MS/MS and GC-MS/MS platforms
- Ultra-trace detection at sub-ppb levels
- Full validation: specificity, accuracy, precision, LOD, LOQ, linearity, robustness
Each method is designed for high sensitivity and reproducibility across various drug matrices, including IR, ER, and complex formulations.
Learn more about method development
3. Confirmatory Testing at Nitrosamine Analysis Laboratory
Once the method is validated, we move to confirmatory nitrosamine testing, where samples are analyzed under strict QA/QC conditions.
Our nitrosamine analysis laboratory performs:
- Screening and quantitation of known and emerging nitrosamines
- Analysis of APIs, finished products, and excipients
- Batch release and regulatory submission support
Turnaround times range from 5–10 business days, with expedited options available.
Common Nitrosamines Tested at ResolveMass Laboratories
Our nitrosamine analysis laboratory routinely screens for the following nitrosamines:
- NDMA (N-Nitrosodimethylamine)
- NDEA (N-Nitrosodiethylamine)
- NMBA (N-Nitroso-N-methyl-4-aminobutyric acid)
- NEIPA (N-Nitrosoethylisopropylamine)
- NDIPA (N-Nitrosodiisopropylamine)
- NDBA (N-Nitrosodibutylamine)
- NPIP (N-Nitrosopiperidine)
- NMPA (N-Nitrosomethylphenylamine)
- NDSRIs (Nitrosamine Drug Substance Related Impurities) – Customized synthesis and testing available
Our lab can also adapt methods to detect newer nitrosamines flagged by regulatory authorities or specific to your synthesis route.
Full impurity testing list here
Scope of Nitrosamine Analysis Laboratory Services at ResolveMass Laboratories
ResolveMass Laboratories offers a full suite of nitrosamine testing services that go beyond simple detection:
- Regulatory risk assessments: We assess your formulation and manufacturing processes for nitrosamine risk.
- Screening and confirmatory testing: Rapid and accurate detection of nitrosamines, including newly identified NDSRIs.
- Batch release testing: Ongoing testing for compliance and market authorization maintenance.
- Stability testing: Long-term and accelerated testing to monitor nitrosamine formation over time.
Comprehensive service breakdown here
Why Pharmaceutical Companies Trust ResolveMass as Their Nitrosamine Analysis Laboratory
We understand that choosing the right partner for nitrosamine testing is not just about capability — it’s about consistency, reliability, and trust. ResolveMass is an independent, GLP-compliant nitrosamine analysis laboratory that works closely with regulatory teams, QA departments, and formulation scientists to ensure data integrity and actionable insights.
- Transparent communication and rapid turnaround
- Extensive reporting tailored to Health Canada, FDA, and EMA needs
- Dedicated scientific liaisons for project coordination
- ISO/IEC 17025-aligned internal protocols
Frequently Asked Questions (FAQs)
What turnaround times can we expect?
Standard confirmatory nitrosamine testing is completed within 5–10 business days. Urgent testing and expedited projects can be accommodated upon request.
Can you develop custom methods?
Absolutely. Our nitrosamine analysis laboratory routinely develops and validates custom LC-MS/MS or GC-MS/MS methods for complex or novel matrices, including poorly soluble APIs and fixed-dose combinations.
What drug products do you specialize in?
We’ve supported testing for small molecules including ARBs, antidiabetics, proton pump inhibitors, and antibiotics — with expertise in both immediate-release and controlled-release dosage forms.
How to Engage ResolveMass for Nitrosamine Analysis Laboratory
Getting started with ResolveMass is simple:
- Initial Consultation: Share your compound details, target nitrosamines, and formulation matrix.
- Project Planning: Our team will develop a testing strategy tailored to your needs and regulatory timelines.
- Testing & Reporting: We’ll execute testing with full documentation suitable for submission.
Whether you need a one-time analysis or long-term support across your portfolio, ResolveMass offers a seamless partnership as your nitrosamine analysis laboratory.
Links to Explore
- Nitrosamine Confirmatory Testing Services
- NDSRI Impurity Synthesis Support
- Nitrosamine Risk Assessments for Drug Substances
- LC-MS/MS Nitrosamine Screening
- Batch Testing and Long-Term Monitoring
Ready to Work with a Leading Nitrosamine Analysis Laboratory?
ResolveMass Laboratories delivers precision, compliance, and scientific rigor in every nitrosamine project. With proven technical expertise, validated infrastructure, and client-centric workflows, we are the trusted nitrosamine analysis laboratory for pharmaceutical innovators and manufacturers.
Let’s talk about how we can support your regulatory and quality assurance goals.
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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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