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 ...

All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities. The safety of a drug product is as important as its effectiveness. Testing a drug for ...

Intelligent analytical tools detect impurities to help ensure the quality of small-molecule drug ingredients. The United States Pharmacopeia (USP) defines an impurity as “any component of a drug ...

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 ...

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 ...

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 ...

Elemental impurities in pharmaceutical products represent a critical area of research, driven by heightened regulatory scrutiny and a growing imperative to ensure patient safety. Such impurities, ...