关于欧洲药典的方法中杂质控制的疑惑?你看看有没有“other detectable impurities (the following substances would,if present at a sufficient level, be detected by one or other ofthe tests in the monograph. they are limited by the generalacceptance criterion for other/unspecified impurities and/orby the general monograph substances for pharmaceuticaluse (2034). it is therefore not necessary to identify theseimpurities for demonstration of compliance.”类似的话,按照目前的要求来看,如有高于0.1%杂质,还是需要单独定性、定量的查看更多