Science-based solutions for controlling nitrosamine impurities in medicines

Elevated levels of nitrosamines – a probable carcinogen – have been found in some commonly prescribed medicines. They pose a risk of physical harm to patients and can undermine trust in medicine quality, harming patients who may be reluctant to take the medicines they need to stay healthy.

Nitrosamine impurities can disrupt drug supply chains and even lead to shortages resulting from product recalls and withdrawals.

Industry and regulators grapple with challenges in both nitrosamine detection and control. More recently discovered Nitrosamine Drug-Substance Related Impurities (NDSRIs) have further complicated the issue.

Leading with the science: Read the latest from USP authors

Quality Matters

USP Nitrosamine-Related Solutions

USP is supporting manufacturers and regulators with science-based solutions for testing, assessing risk and identifying potential sources of nitrosamines. USP is also providing educational resources and ways to connect with and learn from experts in the field and others tackling similar nitrosamine challenges.

USP General Chapter <1469> Nitrosamine Impurities provides information on developing testing methodologies to detect and measure nitrosamine impurities in drug ingredients and drug products.

USP’s official Reference Standards and Pharmaceutical Analytical Impurities are physical samples that can serve as a benchmark for impurity analysis.

USP Education resources provide practical information on sources of nitrosamine impurities in drugs as well as strategies for controlling them in both live and self-paced courses.

Perspectives from USP about nitrosamine impurities

pill pictured under magnifying glass
2023: A year of Nitrosamine milestones
Global cooperation essential to safeguarding patients
group of people around a conference table
Insights from India: Q&A with USP nitrosamines expert