Where can I find the content assigned to a reference standard used in an assay? - 分享质量人的知识和经验

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Where can I find the content assigned to a reference standard used in an assay?

Where can I find the content assigned to a reference standard used in an assay?

在哪里可以找到用于含量测定的标准物质的标示含量？

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青云之上一阶会员用户来自于: 广东省深圳市
2023-10-24 22:25

When required by the prescribed test and/or assay of the corresponding Ph. Eur. text, the content of a CRS is given in the leaflet available in the Ph. Eur. reference standards database.
当欧洲药典中规定的检测项目和/或含量测定需要某标准物质的标示含量时，此标准物质的标示含量可以在欧洲药典标准物质数据库中的说明书中找到
For impurity CRSs used for quantification in the related substances test of the corresponding Ph. Eur. monograph, the content can be assumed to be 100%, unless otherwise indicated in the leaflet.
在欧洲药典各论中有关物质定量检测中使用的标准物质，除非说明书中另有规定，含量值可以假定为100%。
In all other cases, no value is assigned and no assumption can be made on the purity or content of the reference standard.
其他所有情况下，对标准物质的纯度或含量不赋值，也不做假设。

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发布时间: 2023-10-24 20:59

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