Nitrosamine impurities have been classified by regulatory and authoritative bodies as probable human carcinogens. There have been numerous product recalls after unacceptable levels of nitrosamines have been discovered in some medicines.  In September 2020 the FDA issued new guidance for industry on the ‘Control of Nitrosamines in Human Drugs’ with recommendations of steps manufacturers of API’s and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance recommends a risk assessment for the presence of nitrosamine impurities, with confirmatory testing using validated analytical methods to be conducted when there is any risk for the presence of nitrosamine impurities. 


In this webinar, our expert Michael Walker, describes High Resolution Accurate Mass Spectrometry - a validated method for the quantification of nitrosamine impurities in pharmaceutical products and key considerations for its use in a regulatory setting.


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