What's new in testing pharmaceuticals for metals: metals and limits in limbo

Between the EMA, EP, USP, and ICH, there are major differences between the listing of elements and the compliance limits for each element. USP departed from the EMA and EP by including the "Big 4" (As, Cd, Hg, and Pb), potential inadvertent contaminants. Additionally, USP did not include some of the elements listed in the EMA and EP because the limits for those elements were very high, and failure to comply with those limits would represent a GxP failure first.