FDA issued an alert today that it has detected “excessive levels of peroxide in one lot of Crospovidone (cross linked polyvinyl N-pyrrolidone) manufactured by China-based Tianjin Boai NKY International Ltd.” Although there have not been any related adverse-event reports to date and although the level of peroxide found does not pose a major health risk, said the agency in an advisory statement yesterday, there is concern that elevated levels of peroxide can cause “subpotent finished products.”
In fact, the peroxide level found by FDA in the lot was more than four times the maximum level of peroxide (400 ppm) that is recommended in compendial monographs. This particular ingredient, crospovidone, is very common in drugs and dietary supplements.
Specifically, “FDA is concerned that drug manufacturers using excipients containing high levels of peroxides will observe a loss of drug potency and the formation of excessive impurities during the product shelf life.”
Although details are still being determined as to the cause of the peroxide level, the situation likely does not bode well for Chinese pharmaceutical manufacturers and suppliers. Heparin and melamine contaminations have been traced back to China over the past couple of years and another major problem may just be the third strike.
More information about the advisory are on are on the FDA website.