What Are the Crucial Criteria for Staying Ahead in Nitrosamine Testing?
Explore qualitative and quantitative solutions for nitrosamine testing. Gain expert insights on developing robust methods for nitrosamine impurities and raw materials testing in the pharmaceutical industry. Additionally, discover tips for adapting gas chromatography mass spectrometry (GCMS) and liquid chromatography mass spectrometry (LCMS) systems to enhance product safety.
To assist you in navigating this challenging landscape, we have developed a whitepaper that serves as an authoritative guide to proactive nitrosamine testing and control strategies. This resource not only offers insights into effective assessment methods but also provides a thorough understanding of the FDA guidelines and the regulatory landscape surrounding nitrosamine analysis. By equipping you with this knowledge, we aim to empower you to continue your drug development journey with confidence.
Key Insights:
- Sensitive, flexible, and robust nitrosamine analysis methods
- Address analytical challenges in LC/MS
- Future-focused validation criteria for evolving regulations
- Minimizing assay development variability sources
- Case study demonstrating techniques surpassing FDA requirements