Product profile and minimum acceptable profile assay results.
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Note: TLC = Thin Layer Chromatography sheet; FP = Filter paper.*Least amount of substance needed to be detected by the assay, LOD.**Both qualitative and quantitative results will be needed:– By definition – counterfeit ARTS preparations don't contain the active ARTS ingredient and it is most unlikely that one artemisinin derivative will be substituted by another.- By definition – substandard drugs may contain a lower dose of active ingredient, may contain ARTS degradation products or be subjected to other lacks of conformity due to poor good manufacturing practice.
创建时间:
2015-12-02



