In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to ...

Nitrosamine impurities became a topic of focus when health regulators recalled valsartan, an antihypertensive drug, due to the presence of N-nitrosodimethylamine (NDMA), a probable carcinogenic agent ...

Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and ...

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle. The safety of a drug product is as important as its effectiveness. Testing a drug for ...

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 ...

Magnesium silicide (Mg2Si) is a thermoelectric material that can convert heat into electricity. Though it is known that adding antimony impurities enhances the performance of Mg2Si, the mechanisms ...

Over the past three years, millions of blood pressure pills that contain a probable carcinogen have been recalled around the world. As pharmaceutical companies have worked on finding a fix, they’ve ...

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 ...