Nitrosamine Impurity Analysis — Confidence in compliance — Confidence in results

Why is nitrosamine impurity analysis in drugs important?

Nitrosamines, or more correctly N-nitrosoamines, refer to any molecule containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human carcinogens. The unexpected finding of nitrosamine impurities in drugs such as angiotensin II receptor blockers (ARBs), ranitidine, nizatidine, and metformin, has made clear the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk for their presence. Stringent regulatory guidance’s are not only helping to make drugs safer, but through the method requirements are helping laboratories to identify the appropriate tools needed for accurate and confident analysis.

Single Solution GMP Compliance

Topics covered in this toolkit include:

  • Up-to-date regulatory guidance and methods
  • Consolidated solutions and the problems they over-come
  • High throughput approaches for routine screening
  • Benefits of High Resolution Accurate Mass (HRAM) in this space
  • How to get a handle on nitrosamine formation through ingredient 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:

  1. Discover how our tools are applied by industry leaders
  2. Understand how streamlined tools can be used in your laboratory
  3. Learn about Thermo Scientific software, instruments, and consumable solutions for nitrosamine analysis
  4. Benefits of a single-solution software platform for every analysis

Please complete this form to access the free nitrosamine tool kit.

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