Mutagenic impurities

This abstract image represents ion mobility as used in IMS-MS, a key technology for nitrosamine detection in pharmaceutical quality control. By visualizing particle separation, it underscores IMS-MS's role in ensuring regulatory compliance and improving impurity profiling.
ArticlesUnderstand the essentials of QbD for HPLC and create robust, reproducible methods for pharmaceutical applications.
Blogs
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Learn more about the risk assessment and analytical challenges of detection and quantification of trace level impurities in pharmaceuticals.
BlogsAnalysis of nitrosamines in pharmaceuticals presents certain unique challenges - interferences, elevated baselines, inconsistencies in quantifications, decreased method performance.
BlogsWhy are there nitrosamines in drug substances and drug products, and what are the current regulatory guidance’s to help identify these mutagenic impurities?