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.
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.
