Nitrosamine Analysis

In response to nitrosamines present in pharmaceutical products, the European Medical Agency (EMA) and the US Food and Drug Administration (US FDA) have published requirements and limits related to nitrosamine contaminants. Therefore Brightlabs has developed and validated multiple methods to determine low level concentrations of Nitrosamines. These methods can easily be adapted to different drug substances or drug products. For you as a pharmaceutical manufacturer, these methods can help in a proactive approach as part of a risk assessment of your products. Brightlabs has an in-house developed and validated method for the determination of low level Nitrosamines screen using GC-MS/MS. All nitrosamines as listed by the EMA are present in this method, and can be measured in very low levels, even as low as < 1 ppb depending on the product and nitrosamine.