【求助】ANDA:Impurities in the drug substance 中一句话
这个帖子发布于 10 年零 248 天前，其中的信息可能已发生改变或有所发展。
if the level of a specified impurity is above the level specified in the USP, we recommend qualification. Then, if appropriate qualification has been achieved, an applicant can petition the USP for revision of the acceptance criterion.这句话怎么理解？特定杂质的水平怎么会高于USP呢
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