在ICH中Q2R1中对accuracy是这样要求的 a) application of an analytical procedure to an analyte of known purity (e.g. reference material); b) comparison of the results of the proposed analytical procedure with those of a second well-characterized procedure, the accuracy of which is stated and/or defined c) accuracy may be inferred once precision, linearity and specificity have been established. 按照a)和b)方法来操作的话最后应该都是做加样回收率吧,具体怎么做加样呢?我只是听说过还没有自己做过。国标中说的ICH推荐在标示量的80%、100%和120%的水平上,是分别在这三个水平上加样还是怎么做呢?限度应该怎么确定,有通常的范围么?