Introduction: The Consequences of Nitrosamine Detection in Generic Medicines
In recent years, the pharmaceutical industry has become increasingly concerned about nitrosamine impurities found in medications. Nitrosamine testing for generics has now become essential due to the risks these impurities pose, including product recalls and heightened regulatory scrutiny. For generic drug manufacturers, regular testing is no longer optional—it’s a critical part of ensuring drug safety and compliance. Beyond regulations, this testing plays a key role in protecting patients from potential long-term health issues.
At ResolveMass Laboratories, we offer advanced testing services that help companies stay compliant with international standards. Our team of experienced scientists supports generic drug developers through every stage of the nitrosamine risk assessment and testing process.
What Are Nitrosamines and Why Are They Dangerous?
Nitrosamines are chemical compounds that can form accidentally during the drug manufacturing process. This happens when certain materials, like amines, react with other substances under specific conditions. These reactions can occur during production, packaging, or even storage.
Some nitrosamines, like NDMA and NDEA, are considered likely to cause cancer in humans. Because of their toxic nature, health agencies such as the FDA, EMA, and Health Canada have placed strict limits on how much of these impurities can be present in medications. Even tiny amounts can pose a serious long-term health risk.
Why Testing for Nitrosamines Is Required in Generic Drugs
Generic drugs are expected to match branded drugs in both quality and safety. However, because generics can have different ingredients or manufacturing steps, they may face unique risks of contamination. That’s why global regulators now require strict nitrosamine testing for generics—from development through post-approval stages.
This testing is not a one-time task. Changes in suppliers, materials, or manufacturing sites can increase the risk of contamination. Ongoing testing is needed to make sure the product stays safe throughout its lifecycle.
Regulatory Guidelines That Govern Nitrosamine Testing
Health agencies around the world have put in place clear rules for nitrosamine control:
- FDA (2020): Requires all ANDA holders to assess the risk of nitrosamines and take corrective actions.
- EMA: Demands full testing and evaluation of existing and new generic products.
- Health Canada: Expects detailed risk assessments supported by strong scientific data.
ResolveMass Laboratories helps manufacturers meet all these requirements with complete testing services and documentation designed to satisfy each agency’s expectations.
ResolveMass offers full CRO support to assist generic developers in meeting these global requirements.
Which Generic APIs Are Most at Risk?
Some generic drugs are more prone to nitrosamine formation due to their chemical structure or how they are made. Common high-risk APIs include:
- Sitagliptin: Needs special testing due to its potential nitrosamine precursors. See our testing expertise in sitagliptin APIs
- Betahistine: Requires tight control during synthesis. Learn more about testing in betahistine
- Cinacalcet: Demands custom analysis methods. We provide tailored methods for cinacalcet
- Amitriptyline: Needs detailed testing to find even trace levels of impurities. Our scientists offer specialized analysis for amitriptyline
Every drug is different, and ResolveMass Laboratories conducts customized NDMA/NDEA testing based on API reactivity and process pathways.
Our 4-Step Scientific Method for Nitrosamine Testing
Step 1: Identifying and Assessing Risk
We begin by reviewing the entire manufacturing process, raw materials, and packaging to locate any possible sources of nitrosamines. This step is guided by our proprietary risk assessment tools. Our nitrosamine risk assessment guide outlines a systematic methodology.
Step 2: Testing with Advanced Technology
ResolveMass uses top-tier techniques like LC-MS/MS and GC-MS. These methods can detect nitrosamines at parts-per-billion levels, ensuring precise and reliable results. We provide LC-MS/MS and GC-MS based confirmatory testing that aligns with global standards.
Step 3: API-Specific Testing Panels
We customize our testing based on the drug being analyzed. For example, the methods used for amitriptyline are different from those used for cinacalcet. This ensures that no impurity is missed.
Amitriptyline-specific testing
Step 4: Regulatory-Ready Reports
All our reports include validation data, testing outcomes, and mitigation steps. They are formatted to meet ICH M7, FDA, and EMA standards—making regulatory submission easier for our clients.
Why Nitrosamine Testing for Generics Matters More Than Ever
The spotlight on drug safety has intensified, and generic developers can no longer overlook nitrosamine risks. Whether you are bringing a new product to market or maintaining an existing one, nitrosamine testing for generics is now essential. At ResolveMass Laboratories, we combine scientific accuracy with regulatory knowledge to help clients prevent contamination and meet compliance.
We ensure your products stay safe, effective, and ready for market approval—no matter where you operate.
Explore our capabilities in nitrosamine analysis.
Why ResolveMass Laboratories Is the Right Partner
- Extensive Expertise: Our team is skilled in impurity profiling and method development.
- Regulatory Knowledge: We stay updated on FDA, EMA, ICH, and WHO guidelines.
- Customized Testing: Every drug gets its own targeted testing protocol.
- Fast Results: We deliver detailed reports in 5 to 20 business days, depending on complexity.
Get started with a custom consultation at our nitrosamine testing lab.
Final Thoughts: Make Nitrosamine Testing a Core Strategy
With rising concerns about contamination, nitrosamine testing is no longer a “nice to have”—it’s a must. Generic drug makers need to take active steps to test and control for these impurities. Doing so not only protects patients but also prevents costly recalls and regulatory setbacks.
Let ResolveMass Laboratories be your trusted partner in achieving full compliance. From start to finish, we help ensure your generics are safe, high-quality, and ready for the global market.
Need help getting started? Talk to us today:
📩 Contact ResolveMass
📩 Speak to an Expert
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Most Asked FAQs About Nitrosamine Testing for Generics
Nitrosamines are harmful chemicals that may cause cancer if people are exposed to them for a long time. They can damage the body’s DNA and may affect organs like the liver. Because of these serious effects, they are carefully monitored in medicines.
Nitrosamine impurities in medicines can increase the risk of cancer in patients. Even small amounts taken daily over time may be unsafe. That’s why drug companies must test and remove these impurities before selling the product.
Short-term exposure to low levels of nitrosamines may not cause clear symptoms. However, long-term exposure could lead to liver damage or increase the risk of cancer. Regular testing in drugs helps prevent harmful exposure.
Nitrosamines are found using special machines like LC-MS/MS or GC-MS. These tests can detect very tiny amounts of impurities in the drug. Labs like ResolveMass use these tools to make sure medicines are clean and safe.
The cost of nitrosamine testing depends on the number of samples and how complex the drug is. It usually starts from a few hundred dollars per sample. For a detailed quote, companies can contact ResolveMass.
Regulatory bodies have set strict daily limits for nitrosamines. For example, NDMA is limited to about 96 nanograms per day. Staying within these limits helps protect patients from long-term health risks.
Nitrosamine testing should be done during drug development, before approval, and whenever there are changes in the manufacturing process. It’s also recommended to re-test regularly if there’s new guidance or updated safety limits from regulators.
Some active pharmaceutical ingredients (APIs) are more likely to form nitrosamines, especially those with secondary or tertiary amines. Common examples include sitagliptin, amitriptyline, betahistine, and cinacalcet. ResolveMass provides custom testing for these APIs.
ResolveMass Laboratories offers fast and reliable testing services. Depending on the sample type and complexity, results can be delivered within 5 to 20 business days. The team also supports urgent testing for regulatory deadlines.
