IHS Chemical Week

FDA Warns on Contaminated Pharma Ingredient from China

10:47 AM MDT | October 25, 2010 | Deepti Ramesh

The U.S. Food and Drug Administration (FDA) says it is alerting drug and dietary supplement manufacturers, compounding pharmacies and distributors of povidone analogs that the agency recently detected excessive levels of peroxide in one lot of crospovidone (cross linked polyvinyl N-pyrrolidone) manufactured by Chinese firm Tianjin Boai NKY International. Crospovidone is a common ingredient in drugs and dietary supplements, and peroxide is a potential impurity from the polymerization step involved in the manufacturing of povidone analogs. The peroxide level found...


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