USP Announces Approval of Chapter on Nitrosamines Impurities


These materials are present in some angiotensin II receptor blockers used to treat heart failure and high blood pressure, and they have the potential to cause cancer.

The US Pharmacopeia (USP) announced a new general chapter <1469> about nitrosamines impurities in a new standard in the National Formulary, according to a company statement.

The new standard provides guidance for manufactures and regulators on assessing materials for nitrosamine, which will ensure the performance of analytical procedures to monitor nitrosamine levels in drug products.

“One of the things that makes nitrosamines really tricky is that they actually can be formed very simply through really simple chemistries. The building blocks that you need to create nitrosamines are all around us in nature, and so they can form very easily,” Edwin Gump, PhD, vice president of the Small Molecules Department at USP, said in an interview.

Nitrosamine impurities are present in some angiotensin II receptor blockers used to treat heart failure and high blood pressure, and it has the potential to cause cancer at high levels and with long exposure.

The materials are found in metformin and ranitidine, which led to recalls and an effort to eliminate or reduce these impurities in the drug supply.

“I think a really important job that pharmacists do is making sure that medicines get properly handled, teaching their patients how also to properly handle them. If medicines don't get handled properly or they're stored at conditions that might not be optimal, then there's the chance that these medicines do degrade and could produce some impurities, which if taken to an extreme, could be unsafe,” Gump said.

The USP has been developing solutions and tools to help analyze and monitor impurities in drug supplies. The USP has also led educational events on the topic and developed 8 reference standards for various nitrosamines impurities.


USP standard for nitrosamine impurities becomes official. USP. December 2, 2021. Accessed December 2, 2021. Email.

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