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大家看看这个有关物质的限度

时间: 2008-09-17 06:03:24 作者: 来源: 字号:
这是BP2007一个产品的有关物质限度描诉

In the chromatogram obtained with solution (1) the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%) and the area of not more than one such peak is greater than 0.3 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%)

我的理解是
在溶液一的色谱图中.任何一个副峰不得超过溶液(2)色谱图主峰面积(即1%),一个这样的峰面积至多不超过溶液(2)主峰面积的0.3倍(即0.3%)
大家看看这句话该如何理解,如果该理解是对的,那么单个杂质限度到底是小于0.3%还是1.0%,如果是小于0.3%,第一个限度就没有意义了.而且杂质的总限度是多少呢?大家讨论一下
A secondary peak is a peak in the chromatogram other than the principal peak and any peaks due to internal standard, solvent and derivatising agents.

我的理解是应该是总杂质不得超过1.0%; 很可能药典中内容有误。

不知道是否指的是这个品种:Betaxolol Eye Drops, Solution

您可以参照其原料药的有关物质限度: Inject 20 µl of each solution. Continue the chromatography for at least four times the retention time of the principal peak in the chromatogram obtained with the test solution. In the chromatogram obtained with the test solution: the area of any peak apart from the principal peak is not greater than 0.3 times the area of the peak in the chromatogram obtained with reference solution 各杂质总和不得过1.0%,且大于0.3%的杂质个数应不得多于1个。
应该是任何杂质峰不大于1%,超过0.3%的杂质峰不得多于1个。
同意season08的意见
同意season的意见,单个杂峰不得过1%,超过0.3%的峰最多一个。

换言之,其中一个杂峰面积在区间【0.3%,1%】之间,则其他杂峰则小于0.3%。标准没有规定总杂峰限度
恩,有道理.有关物质没有总限度可以吗

同意season的意见,单个杂峰不得过1%,超过0.3%的峰最多一个。

换言之,其中一个杂峰面积在区间【0.3%,1%】之间,则其他杂峰则小于0.3%。标准没有规定总杂峰限度

同意season08的意见
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