Nitrosamine Impurity Analysis: Every Tool You Will Ever Need

Once every now and again a topic hits the headlines in the analytical world so hard that within a year everybody is talking about the best way to solve the problem, and the best solutions to use. Everyone can “do it the best” or has the right piece of kit for this part — or that part. It’s frankly a tough challenge trying to decide which route to take.

Recently pharmaceutical manufacturers have had such an event. Nitrosamine compounds were found in high levels of certain drug products, and the regulatory bodies worldwide (appropriately) were all over the issue, almost immediately laying out the requirements they would like to see implemented as soon as possible to reduce risks and monitor levels of these impurities. Pharmaceutical companies back then, and still now have decisions to make as to the best route to both meet the potential huge scale of analysis with routin…. Being data driven is more important than ever, but with many different directions having been explored, and many different desirable analytical strategies to ensure product safety, that’s a lot of data to look at. How do you narrow it down to look at the right solutions for your lab?

Consolidated toolbox of solutions

Method development strategies can be broken down into a few key analytical and regulatory requirements, which you may need all or some of depending on the services your lab offers, but it’s important that you can identify the right tool for the job. To filter out the noise you can access this toolbox of solutions, which really keeps things simple and provides great analytical strategies for high-throughput routine monitoring, product assessment, method development and confirmatory testing, and pre-cursor monitoring (to assess the likelihood of impurity formation) in storage.

As well as proof data you also can access presentations and examples from labs within the industry on what works well and you can ask questions of the experts via live webcasts with Q&A.

Topics covered in this toolkit include:

Up-to-date regulatory guidance and methods
Consolidated solutions and the problems they overcome
High-throughput approaches for routine screening
Benefits of High-Resolution Accurate Mass (HRAM)
How to get a handle on nitrosamine formation through raw material testing
Applying the solutions in real life: Hear from global experts in nitrosamine analysis and how they have utilized the tools for success

Learning points

Discover how Thermo Fisher’s tools are applied by industry leaders
Understand how streamlined solutions can be used in your laboratory
Learn about Thermo Scientific software, instruments, and consumable solutions for nitrosamine analysis
See the benefits of a single-solution software platform for every analysis

ACCESS TOOLKIT NOW To hear more about how these techniques can help with your analysis, and to ask questions about how these are being successfully implemented in industry, register for this short webinar series covering a range of nitrosamine techniques. Webinars: Learn more Related blog posts Overcoming the Challenges of Nitrosamine Analysis What are Nitrosamines and Why Should I Care? 5 Ways to Become a Nitrosamine Ninja