The nitrosamine impurity crisis continues to be on the mind of every stakeholder involved in the development and manufacturing of affected drug products. In our interactions with key opinion leaders and those in the lab having to develop and validate nitrosamine testing methods, we’ve come across a few common questions that we want to address here
The recent nitrosamine impurity crisis has brought into question the quality of many APIs (Active Pharmaceutical Ingredients) produced and sourced for a number of popular drugs, resulting in product recalls, lost profits, and regulatory actions.… Read more >
