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 ...

Chemical purity is the most important quality characteristic of a pharmaceutical substance. This article describes the latest scientific and technological advances to meet recent pharmacopoeial and ...

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 ...

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 ...

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 ...

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 ...

Drug manufacturer Teva issued a Class 2 recall for over half a million bottles of prazosin hydrochloride because testing revealed impurities at levels linked to cancer. In a Class 2 recall, stopping ...