Nitrosamines in Pharmaceutical Waters: Origins, Risk Mitigation, and Testing Requirements

Nitrosamines are organic compounds, long known to be probable carcinogens, yet are found in low level concentrations in air, water, soil, and food.  Both FDA and EMA have outlined a three step framework for mitigating or preventing the presence of nitrosamines in medicinal products which includes the following: Water has been identified as a potential … Continue reading Nitrosamines in Pharmaceutical Waters: Origins, Risk Mitigation, and Testing Requirements