Addressing the saga of nitrosamine contamination in drugs | Business

In June 2018, a potentially carcinogenic nitrosamine impurity, N-nitrosodimethylamine (NDMA), was detected in valsartan, a medication used to treat high blood pressure and heart failure. Soon after, NDMA and further small dialkyl N-nitrosamine impurities were discovered in other sartan active pharmaceutical ingredients (APIs), and later in stomach acid regulator ranitidine, and diabetes medicines piaglitazone and metformin.

‘At that time, the risk was related to the manufacture of the drug substance,’ explains Andrew Teasdale, senior principal scientist in impurity management at…