主题:【求助】应助 TLC 翻译一句话

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ghost555
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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,还是unspecified impurity????

请见下文的附件。
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577553322
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577553322
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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????
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ghost555
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原文由 577553322 发表:
any other impurity

我也这样看了,但客户的邮件说:
This means that the value 1.0 % comprises any spot corresponding to any impurity including the spot corresponding to impurity A. So mentioning of “total impurities” as given on your COA before was completely right.

请大家留言!!谢谢!
happyjyl
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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????


这句话里指的当然是单个杂质(也包括杂质A)。但是这句话不符合常理。药品里单个杂质的限度不可能那么高的,通常也就是0.1%-0.5%。单个杂质的限度都为1.0%,那总杂质得有多高了?一般来说,1.0%或以上的都应该是指总杂质。

联系你客户邮件的内容,我猜是你们先后给客户出过两份COA,第一份上提到“total impurities”的限度是1.0%;第二份也是想表达这个意思,但漏了一个词“total”,故而表达成了“单个杂质”的意思。客户的邮件里,第一句话是指明你们的第二份COA所犯的错误,第二句话是说第一份COA里关于总杂质的表达是正确的。

以上为猜测,最好详细交代下来龙去脉。
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ghost555
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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?

impurity A and related substances
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sipingniu
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happyjyl
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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。
ghost555
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7 楼HAPPY的理解是对的,我也比照过了。但在EP中除了对specified impurity (A)进行了控制,还对unspecified impurity进行了控制,但最后这句话中,到底是说total,还是single杂质???

再次感谢happy的及时帮助!!
happyjyl
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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%。
ghost555
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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%。


我也是这样理解的,这正是我根客户的争议所在。不过我也在想单个杂质怎么这么大,总杂质的限度,我们是不是要另外进行规定。。。。
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