Download your copy of the 'Overcoming the Challenges of Trace Nitrosamine Detection and Quantification in Pharmaceutical Products' Technology Guide...

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Expert Insights Interview
Separation Science met with Agilent experts to discuss root causes for the presence of nitrosamines in drug substances and drug products, the current regulatory guidance to help identify these mutagenic impurities, the key analytical strategies that can be used to analyze mutagenic impurities, and the role that modern GC/MS instruments can play in routine nitrosamine applications.

 

Tips and Tricks for Analysis of Nitrosamine Impurities in Pharmaceuticals
Analysis of nitrosamines in pharmaceutical products presents certain unique challenges in terms of interferences, elevated baselines, inconsistencies in quantification and decreasing method performance. Experts share tips and tricks that they learned analyzing these complex, yet critical impurities.

 

Application Notes
Here we present a series of recent GC/MS applications including the analysis of five nitrosamine impurities in drug products and drug substances using GC/MS/MS, combined analysis of N-nitrosodimethylamine and N-nitrosodiethylamine using a headspace sampler and GC/MSD system, and quantification of nitrosamine impurities in metformin using GC/MS/MS.

 

Resources
A selection of additional educational assets to further your knowledge and to increase your confidence in your analysis of trace nitrosamine in pharmaceutical products.

 

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