原文由 ghost555 发表:
In the chromatogram obtained with test solution (a),any spot apart from the principal spot and any spot corresponding to impurity A is not more intense than the spot in the chromatogram obtained with reference solution (c) (1.0 per cent)
请教,这里说的是total impurities, 还是any other impurity????
[/qu
各位大虾:谁能帮我找一下JJG711-1990啊?谢谢啊
原文由 577553322 发表:
any other impurity
原文由 ghost555 发表:
In the chromatogram obtained with test solution (a),any spot apart from the principal spot and any spot corresponding to impurity A is not more intense than the spot in the chromatogram obtained with reference solution (c) (1.0 per cent)
请教,这里说的是total impurities, 还是any other impurity????
原文由 ghost555 发表:
请打开附件,impurity A and related substances部分。谢谢!
我也明白ICH Q3 <2g,一般杂质要小于<0.1%,否则要确证结构。但这里会不会是专论中另有规定的例外呢?
原来是EP专论啊。参考了一下USP和ChP,这个药的确跟一般的药品不太一样。
首先,EP里收载的杂质只有杂质A(硫脲),而且含量较低(限度为0.05%),说明这个药品本身的杂质就不多,比较纯。再看ChP,对硫脲只是通过比色法来控制(颜色不得深于空白)。USP里更是没有提到硫脲,只是用TLC法对ordinary impurities作了控制,规定总杂质不得超过2.0%。可见USP、EP和ChP对丙硫氧嘧啶中的杂质都控制得不严。
原文由 happyjyl 发表:
In the chromatogram obtained with test solution (a), any spot corresponding to impurity A is not more intense than the spot in the chromatogram obtaine with reference solution (b) (0.05 per cent) and any spot [apart from the principal spot and any spot (corresponding to impurity A)] is not more intense than the spot in the chromatogram obtaine with reference solution (c) (1.0 per cent).
请看我用[]和()括起来的部分。我的理解是除主斑点和杂质A对应的斑点外,其它任何单个杂质的限度是1.0%。