Industry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities. Medicine regulatory authorities were alerted of the presence of the ...

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients. Effective and safe APIs provide the necessary ...

In 2018, a nitrosamine impurity (N-nitrosodimethylamine or “NDMA”) was detected in several pharmaceutical drugs containing the active ingredient valsartan, which resulted in a voluntary product recall ...

Pharmaceutical process chemists want to make the compound, the whole compound, and nothing but the compound. They know, however, that chemistry isn’t that simple and that a multistep synthesis often ...