Understand evolving global regulations and analytical strategies to mitigate nitrosamine risks
The unexpected discovery of nitrosamine impurities in active pharmaceutical ingredients (APIs) in 2018 reshaped the regulatory landscape for drug safety. Recognized as probable human carcinogens, nitrosamines prompted widespread product recalls and new regulatory frameworks designed to safeguard public health.
Our latest white paper explores how global regulators, including the EMA, FDA, MHRA, and PMDA, have developed harmonized guidelines for assessing and mitigating nitrosamine risks. It also highlights how pharmaceutical manufacturers can adopt structured, risk-based approaches – from assessment and confirmatory testing to long-term prevention strategies – to maintain compliance and protect patient safety.
