Nitrosamine excipient risk refers to the potential formation or presence of nitrosamine molecules, including tertiary nitrosamine species and volatile nitroso compounds, within pharmaceutical excipients. These may occur as nitrosamine industrial impurities or as nitrosamine detected impurities originating from contaminated raw materials, manufacturing conditions, storage degradation, or interactions between APIs and excipients containing nitrosamines precursors such as nitrites and amines. Such risks place certain materials under nitrosamine monitored substances and nitrosamine compliance substances, where nitrosamine compliance triggers are activated by adverse nitrosamine findings. Given their strong genotoxic potential at trace levels, regulatory authorities require robust risk assessments, monitoring, and mitigation controls to ensure patient safety.
Manasa Life Science is a reliable manufacturer and global supplier of nitrosamines and N-nitroso compounds, providing high-purity reference standards for research applications, analytical method development, and regulatory compliance. Our product portfolio supports precise detection and measurement of nitrosamine impurities in pharmaceuticals, food, and other matrices, including widely monitored compounds such as NDMA, NDEA, NDPA, and NDBA. A complete list of available products can be found on our website.