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.
What you’ll find in our white paper
- Global regulatory evolution
Discover how major agencies (EMA, FDA, Health Canada, MHRA, and PMDA) have responded to nitrosamine contamination with coordinated guidelines, risk assessment frameworks and acceptable intake (AI) limits.
- The risk-based approach explained
Understand the phased regulatory process for risk evaluation, confirmatory testing and marketing authorization updates – and how to implement these measures across your product portfolio.
- Analytical and mitigation strategies
Explore how we apply advanced analytical methods, including nitrite testing, forced degradation studies and excipient compatibility testing, to identify and mitigate nitrosamine formation risks.
- Industry collaboration and scientific advances
Learn how recent FDA and EMA updates, combined with industry-wide research and data sharing, are driving a new phase of education, prevention and innovation in nitrosamine control.