USP’s Nitrosamine Impurity Standard is Now Official

On Dec. 2, 2021, the United States Pharmacopeia (USP)’s new General Chapter <1469> “Nitrosamines Impurities” became official in the United States Pharmacopeia—National Formulary. By providing guidance on assessing for the presence of nitrosamine, establishing control strategies, and monitoring nitrosamine levels in drug products through ensuring the performance of analytical procedures, the new standard supports both manufacturers and regulators.

In 2018, select angiotensin II receptor blockers that treat high blood pressure and heart failure were found to have nitrosamine impurities. Nitrosamines can potentially cause cancer, depending on the levels and exposure. Since 2018, nitrosamine impurities were found in ranitidine and metformin. As a result, there have been multiple recalls. In addition, regulators and the worldwide industry have worked to reduce or eliminate the presence of these impurities.

In addition to the new standard, USP has developed eight reference standards for various nitrosamine impurities. These highly characterized specimens of the impurities can be used by manufacturers to detect the presence of nitrosamines in their products.