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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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, ...
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 ...
LE SSERAFIM is back with a gorgeous new music video! On November 14 at midnight KST, LE SSERAFIM released their music video for “Impurities,” one of the B-sides from their latest mini album ...
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