Genotoxicity evaluation of a valsartan-related complex N-nitroso-impurity.

Recently, the formation of genotoxic and carcinogenic N-nitrosamines impurities during drug manufacturing of tetrazole-containing angiotensin-II blockers has been described. However, drug-related (complex) nitrosamines may also be generated under certain conditions, i.e.

Environmental Metrics to Drive a Cultural Change: Our Green Eco-Label.

A novel Green Chemistry Process Scorecard was developed to assess the environmental impact of chemical production processes to manufacture the Active Pharmaceutical Ingredients (API) within our portfolio. These new metrics not only cover the resource consumption from the overall chemical synthesis, but also consider the use of Substances of Concern and the number of chemical transformations. The Process Mass Intensity (PMI), the ratio of accumulated kilogram quantities of materials per kilogram of API, is used to quantify the resource consumption.