Nitrosamine Testing Services

Pace has a specialized team focused on small-molecule analysis that supports drug development by creating and implementing a wide range of analytical methods. Nitrosamine testing efforts are centralized at a facility and are supported by a larger network of over 1,000 scientists and technicians. This setup offers the advantages of both a dedicated testing site and access to broader scientific expertise within a multidisciplinary research network.

Nitrosamines, which are classified as probable human carcinogens, are subject to stringent regulations from agencies such as the FDA and EMA. These rules typically limit daily exposure to between 26.5 and 1500 nanograms, depending on the specific compound. To avoid ongoing product testing, manufacturers must ensure nitrosamine levels remain below 10% of the allowable intake. These regulations apply to both newly developed and existing drug products.

With extensive experience, the team utilizes advanced instrumentation to detect and quantify nitrosamine impurities, including both solvent-related compounds and Nitrosamine Drug Substance-Related Impurities (NDSRIs). Examine how this analytical expertise can support compliance with current and emerging regulatory requirements.