The global pharmaceutical industry faces increasing regulatory scrutiny over nitrosamine impurities in drug products. In Canada and internationally, regulatory agencies like Health Canada, the U.S. FDA, and the EMA mandate robust Nitrosamine Testing for API Drug Substance to ensure product safety and quality. At ResolveMass Laboratories Inc., we specialize in advanced nitrosamine analysis services to help pharmaceutical manufacturers stay compliant and proactive in 2025 and beyond.
This guide outlines a comprehensive compliance checklist for Nitrosamine Testing for API Drug Substance, emphasizing all steps your organization needs to meet evolving regulatory expectations.
Why Nitrosamine Testing for API Drug Substance is Critical in 2025
Nitrosamine Testing for API Drug Substance is now a non-negotiable requirement across global pharmaceutical supply chains. Nitrosamines are probable human carcinogens, and even trace levels can lead to product recalls or Health Canada non-compliance notices. APIs, due to their reactive nature and synthesis processes, are a significant risk point for nitrosamine formation.
At ResolveMass Laboratories, we provide validated, high-sensitivity LC-MS/MS and GC-MS methods for detecting nitrosamines like NDMA, NDEA, NMBA, DIPNA, and EIPNA. Learn more about our nitrosamine services.
Compliance Checklist: Nitrosamine Testing for API Drug Substance
Use the following checklist to ensure your testing protocols align with current Health Canada and international standards:
1. Conduct a Risk Assessment
- Evaluate the synthetic route of the API.
- Identify potential nitrosating agents and secondary/tertiary amines.
- Assess packaging, solvents, reagents, and process intermediates.
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2. Perform Confirmatory Testing
- Utilize sensitive LC-MS/MS or GC-MS methods.
- Analyze both API and excipients for potential nitrosamine contamination.
- Confirmatory testing is a must if risk is identified during assessment.
3. Develop or Use Validated Methods
- Ensure methods meet LOQ requirements set by Health Canada (often <30 ppb).
- At ResolveMass, we offer method development for complex APIs.
4. Ensure Regulatory-Grade Reporting
- Reports must include method validation data, chromatograms, and impurity profiles.
- ResolveMass delivers GLP/GMP-compliant documentation suitable for regulatory submission.
5. Plan for Routine Monitoring
- Schedule periodic testing for long-term quality assurance.
- Particularly important for APIs produced in multiple facilities or under different suppliers.
How ResolveMass Supports Nitrosamine Testing for API Drug Substance
ResolveMass Laboratories Inc. is a Canadian-based expert in Nitrosamine Testing for API Drug Substance. Our team brings:
- Over 15 years of pharmaceutical analytical experience
- Cutting-edge LC-MS/MS platforms
- Rapid turnaround options (as fast as 48 hours)
- Custom method development & regulatory reporting
We’ve helped dozens of Canadian and international manufacturers meet Health Canada and FDA nitrosamine testing guidelines. See how we do it.
Frequently Detected Nitrosamines in API Drug Substance
During Nitrosamine Testing for API Drug Substance, we most commonly identify:
- NDMA (N-Nitrosodimethylamine)
- NDEA (N-Nitrosodiethylamine)
- NMBA (N-Nitroso-N-methyl-4-aminobutyric acid)
- DIPNA, EIPNA, NDBA, NDIPA
Our validated methods are optimized for detecting these compounds at sub-ppb levels. Request a testing consultation.
Choosing the Right Lab for Nitrosamine Testing for API Drug Substance
When selecting a partner, prioritize:
- Accreditation (GLP/GMP)
- Experience with regulatory audits
- Advanced equipment and qualified personnel
ResolveMass meets all these criteria. We’re one of the most trusted labs for Nitrosamine Testing for API Drug Substance in Canada.
Common Regulatory Pitfalls to Avoid
- Inadequate sensitivity in testing methods
- Missing risk assessments for APIs from multiple sources
- Failure to document nitrosamine risk in regulatory filings
Avoid these issues by partnering with ResolveMass for full-scope nitrosamine compliance.
Conclusion: Stay Ahead with Nitrosamine Testing for API Drug Substance
As regulations continue to evolve, your compliance strategies must remain ahead of the curve. At ResolveMass Laboratories Inc., we help pharmaceutical companies future-proof their operations with reliable, fast, and accurate Nitrosamine Testing for API Drug Substance.
Whether you’re developing a new API or auditing existing supply chains, we are your expert partner for nitrosamine testing in Canada.
Partner with ResolveMass – where science meets compliance.
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
📅 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
