The discovery of nitrosamine-based impurities in APIs has triggered recalls of commonly used drugs and placed the quality of the drug supply in question. Learn best practices for identifying ...
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 ...
It was a U.S. drugmaker that first alerted the FDA that the valsartan API it got from a Chinese ingredient maker contained a potentially dangerous impurity. And in the process of investigating, the ...
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