Analysis of nitrosamines in pharmaceutical products presents certain unique challenges in terms of interferences, elevated baselines, inconsistencies in quantifications and decreasing method performance. Most of these challenges can be addressed by using a cognitive approach towards sample preparation, storage and maintaining the instrument performance:
- Safety first
- Test the blank
- Ensure that the reference analytical standard/internal standard is not a source of contamination
- Avoid plastics as far as practicable
- Matrix considerations
- Other considerations
This useful article is written by Dr Soma Dasgupta (Application Engineer GC & GCMS, Agilent), and forms part of the free-access Technology Guide 'Mutagenic Impurities: GC Strategies - Overcoming the Challenges of Trace Nitrosamine Detection and Quantification in Pharmaceutical Products'.
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