Nitrosamine Testing Policy From European Pharmacopeia’ Largely Aligns With USP

19 Dec 2020

• By Joanne S. Eglovitch

Two groups have issued largely complementary testing methods for measuring nitrosamine impurities in drugs, and the differences that do exist are “insignificant,” EDQM official advises. The two are working to further harmonize testing standards, given the global scope of the nitrosamine scare.

3D illustration of Facsimile Metformin bottle on shelf — European Pharmacopoeia's New General Chapter On Nitrosamine Testing Covers Blood Pressure. Heartburn Meds • Source: Shutterstock

The European Pharmacopoeia has issued a new general chapter that sets testing methods for assessing nitrosamine impurities in blood pressure medicines and other drugs.

The chapter is largely aligned with the US Pharmacopeia's general chapter 1469 recently issued in the US, said an European...