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What is the intended use of EDQM reference standards?

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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 20:55

The EDQM reference standards (chemical substances, herbals and herbal extracts, biological preparations) are established exclusively for the intended use(s) described in the official texts of the Ph. Eur. They are officially valid for the uses prescribed in the Ph. Eur. and represent an integral and essential part of the corresponding monograph(s). Their suitability for any other use is not guaranteed and is the sole responsibility of the user. EDQM reference standards are not intended for human or animal use.
EDQM标准物质(包括化学物质、草药和草药提取物、生物制品)专门为欧洲药典正本中描述的用途而建立。它们对于欧洲药典中描述的用途是正式有效的,并且是药典相关各论中必不可少的基础,但不保证对其他用途的适用性,需要用户自行负责。EDQM标准物质不能用于人和动物。
Certificate of analysis
分析报告
The EDQM does not provide certificates of analysis for European Pharmacopoeia reference standards. The EDQM provides an information leaflet that contains all of the information needed to carry out the tests and assays described in the related monograph(s). This leaflet can be downloaded from the Ph. Eur. reference standards database.
EDQM不提供欧洲药典标准物质的分析报告,提供一个信息说明书,说明书中包含所有各论中进行检测和含量测定的所有信息。该说明书可以从欧洲药典标准物质数据库中下载。


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2023-10-24 20:54
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