Pharmaceutical Analysis

Trace Level Impurities in Pharmaceuticals

This virtual forum discusses the risk assessment and analytical challenges of detection and quantification of trace level impurities in pharmaceutical products including mutagenic nitrosamine impurities.

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 quantifications and decreasing method performance. Most of these challenges can be addressed by...

Identifying nitrosamines in drug products - expert insights

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...

GC/MS strategies for mutagenic impurities analysis

Separation Science, in collaboration with Agilent, offers a technology guide that provides key information for individuals looking to improve knowledge and analytical skills in the trace analysis of nitrosamines in pharmaceutical products. From...

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