- 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.