Pharmaceutical companies around the world are under strict watch by regulatory bodies like the FDA and EMA. This is largely due to the discovery of harmful nitrosamines in certain medications. These impurities are considered potentially cancer-causing, making their detection and control very important. That’s where Nitrosamine CRO support becomes crucial. Contract Research Organizations (CROs) play a big role in helping drug makers find, understand, and control nitrosamine risks to keep medicines safe and meet regulations.
At ResolveMass Laboratories Inc., we offer complete Nitrosamine CRO support with a strong focus on science, regulation, and precise testing. Our expert team and advanced labs help you manage nitrosamine issues quickly and correctly—saving time, money, and most importantly, protecting public health.
What Does Nitrosamine Risk Evaluation Involve?
Understanding and controlling nitrosamines isn’t a one-step task. Nitrosamine risk evaluation is a full, science-based process. It looks at every part of how a drug is made and stored to make sure these harmful chemicals don’t form. This process usually includes:
- Finding the root causes
- Grouping products by risk
- Developing testing methods
- Creating prevention plans
- Preparing documents for regulators
A CRO like ResolveMass leads this process, making sure it’s complete and tailored to each drug. Our job is to ensure you stay ahead of the risk—not react to it after it’s too late.
Why Choose ResolveMass for Nitrosamine CRO Support?
✅ Trusted Scientific Knowledge
Our team includes skilled chemists, toxicologists, and regulatory experts who have worked on nitrosamine challenges in many types of drugs. We stay updated on the latest studies, cases, and rules, so you always get advice that’s both current and practical.
We offer clear, data-based solutions that fit your product’s exact needs. This personalized support ensures real, long-term safety.
Explore our specialized expertise:
👉 Nitrosamine Risk Assessment Guide for Your Drug Product
✅ Complete Testing Services
From your first risk check to confirmatory lab testing, ResolveMass supports every step of the process. We use advanced tools and validated methods that follow all regulations. Every ingredient—from APIs to excipients—is tested carefully to catch even trace levels of nitrosamines.
Discover our capabilities:
👉 Nitrosamine Analysis Laboratory
✅ Strong Regulatory Understanding
Regulations change fast. Our experts keep up with new rules from the FDA, EMA, Health Canada, and ICH M7(R2). We adjust our processes quickly to meet these new standards, so you don’t fall behind on compliance.
Top 10 Ways CROs Help with Nitrosamine Risk Evaluation
1. Full Risk Assessment from Start to Finish
ResolveMass checks every part of your manufacturing process—raw materials, solvents, packaging—to find risks early. Our structured approach helps prevent future problems before they happen.
👉 Read how we assess ND(S)RIs in drug substances
2. Accurate Nitrosamine Testing (NDMA, NDEA & More)
Our labs are equipped with sensitive tools like LC-MS/MS and GC-MS. We detect even very small amounts of nitrosamines, including NDMA, NDEA, NMBA, and DIPNA. Each test is matched to your product’s chemistry.
📌 Nitrosamine Testing in Sitagliptin and Related APIs
3. Custom Testing Methods
Every drug is different, so we build testing methods that work for your specific formula. Our methods follow ICH Q2(R1) guidelines for reliable, repeatable results.
🔍 Nitrosamine Testing in Amitriptyline
4. Finding the Root of the Problem
If nitrosamines show up, we don’t just report it—we find out why. Our team looks at raw materials, processes, and storage to uncover the exact cause and fix it.
5. Ongoing Risk Monitoring
Testing once isn’t enough. ResolveMass offers continuous checks throughout the product’s life. We match our monitoring plans to your drug’s formula and breakdown process.
6. Clear, Compliant Paperwork
We create regulatory documents that follow FDA, EMA, and WHO formats. Our files include all test data, evaluations, and prevention steps—ready for submission without delays. For instance:
We offer deep domain-specific support for critical APIs.
7. API-Specific Risk Knowledge
Some APIs are more likely to form nitrosamines. We have special experience with compounds like Betahistine, Cinacalcet, and others. Our strategies are built around these unique risks.
8. Collaborative CAPA Plans
ResolveMass works with your team to create Corrective and Preventive Actions (CAPA). These are realistic, effective plans that satisfy regulators and solve the problem long-term.
9. Fixing Analytical Gaps
We review your current testing methods to find any weak points. Our gap analysis shows you where improvements are needed to build a strong, defensible nitrosamine strategy.
10. Training and Expert Advice
Need to boost your team’s skills? We offer personalized training and expert consultations. Our goal is to make sure your team can manage nitrosamine risks confidently and independently.
How to Get Started with ResolveMass Nitrosamine CRO Support
Need support? We make it easy to begin. Our team can help you assess your product’s risk, plan testing, and prepare regulatory submissions. Here’s how you can reach out:
📞 Contact us here
📞 Book a technical call
📞 Speak to a nitrosamine expert
FAQs: Top Most Asked Questions about Nitrosamine CRO Support
Antioxidants like ascorbic acid (vitamin C) and alpha-tocopherol (vitamin E) are commonly used as blocking agents to stop nitrosamine formation. They work by interfering with the chemical reactions between nitrites and amines, which are the main sources of nitrosamines. These antioxidants are especially helpful in food and drug formulations to reduce health risks.
Nitrosamine impurities are detected using advanced lab methods like Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS). These techniques are very sensitive and can find tiny amounts of nitrosamines in drug samples. Validated testing methods ensure accurate and reliable results.
To reduce nitrosamine contamination, manufacturers can use high-quality raw materials, avoid nitrosating agents, and improve their manufacturing process. Using antioxidants, changing the chemical synthesis route, or improving storage conditions also helps. Regular testing and working with expert CROs ensures better control and safety.
Nitrosamine risk assessment is a process to check if nitrosamines can form or be present in a drug. It involves studying the materials, manufacturing steps, and storage to find possible risks. If risks are found, testing and corrective steps are taken to ensure safety and meet regulatory standards.
Short-term exposure to nitrosamines might not show clear symptoms, but long-term exposure can increase the risk of cancer, especially in the liver or stomach. Some people may also feel weak or tired. That’s why it’s important to avoid or limit contact with nitrosamines in drugs or foods.
To prevent nitrosamine formation, avoid using amines and nitrites together, especially in acidic or high-temperature conditions. Using stabilizers like antioxidants, adjusting pH levels, and changing chemical pathways during manufacturing can help. Regular quality checks and working with expert labs like ResolveMass also ensure better prevention.
Nitrosamines tend to form more easily at higher temperatures, especially above 130°C. Heat speeds up the chemical reaction between nitrites and amines. That’s why careful temperature control during drug manufacturing and storage is key to reducing the risk of nitrosamine formation.
Some Active Pharmaceutical Ingredients (APIs) are more likely to form nitrosamines because they contain certain chemical groups, like secondary or tertiary amines. Drugs such as ranitidine, valsartan, losartan, metformin, and sitagliptin have shown higher risk. These APIs can react with nitrosating agents during manufacturing or storage, especially under heat or moisture, making them more vulnerable to nitrosamine formation. Regular testing and careful formulation can help control this risk. 🔍 See our work on Sitagliptin
We use triple-redundant checks, internal standard calibration, and ICH-compliant validation protocols to ensure robust and reliable data.
Conclusion:
Nitrosamine-related safety requirements are no longer just industry recommendations—they are strict obligations enforced by global health agencies. Meeting these standards requires expertise, precision, and a clear understanding of evolving regulations. Partnering with a qualified CRO makes it easier to manage these challenges and keep your drug products safe.
ResolveMass Laboratories offers reliable and science-based Nitrosamine CRO support across every phase of your product’s lifecycle. With advanced lab testing, tailored risk evaluations, and regulatory-ready documentation, we help you stay compliant and confident. Our goal is simple: protect your products, your company, and the patients who depend on you.
👉 Start your journey here
👉 Consult our testing lab
👉 Reach our experts now
👉 Book a personalized discussion
