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USP,EP药典标准品常见问题  

2011-04-17 23:17:53|  分类: 药品标准 |  标签: |举报 |字号 订阅

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1.  双层标签问题,可以上EP网站http://www.edqm.eu/site/EDQM_Reference_Standards-649.html 查询,有如下信息:

 

New Labels
The EDQM is currently over-labelling all its reference standards vials with a secondary label.
This new secondary label is useful for customs purposes as it can be peeled off.  It can also be stuck onto your laboratory book to prove the use of the reference standard.  All the required information to perform the tests described in the European Pharmacopoeia monographs are stated on the primary label

 

新标签

EDQM将要把当前所有标准品的外包装瓶上帖上双层标签,目前已经有大部分产品被换成双层标签了,但还有少数部分还没被贴到,还是单层标签。贴双层标签的目的是为了便于使用者在做实验(特别是做认证时)时,把外面的一层标签揭下来贴在所写的实验记录中,以证实这个产品的来源。

 

2.小批次的问题,可以上EP网站http://www.edqm.eu/site/page_630.php?rubrique=180查询,有如下信息:

 

In specific cases, for reasons related to filling and labelling, sub-batches 1.1, 1.2, 1.3, etc., are obtained from the same batch of bulk material.

Notice: the previous classification of the sub-batches 1a, 1b, 1c will be gradually replaced with 1.1, 1.2, 1.3 etc.
However, all the necessary precautions are taken in order to guarantee that the quality and the specifications of the sub-batches do not differ from one to another.

 

在具体情况下,由于填装和贴标等原因,小批次(比如1.1,1.2,1.3等)均是由同一批次的大包装原料药提出来的。请注意:之前小批次的分类称呼将由1a1b1c...逐渐改为1.11.21.3...不过,所有必要的预防措施都必须按照指示进行以保证小批次的标准品的质量和规格不会彼此不同。

 

3.纯度问题:

 

You can obtain it from our catalogue of reference standards, which is available at http://CRS.edqm.eu. If the content is not required to perform the test(s) described in the Ph.Eur. monograph (see also the FAQ about "What is the intended use of CRS/BRP?"), it is not indicated in the catalogue or on the label (or on the leaflet) and you cannot assume the content of a CRS to be 100% for a quantitative test.However, when an impurity reference standard is used in a related substances test for the control of impurity, if no assigned content is stated on the label, the purity of the reference standard, for the purpose of this estimation, is considered to be 100 per cent

 

翻译:可以从http://CRS.edqm.eu 上查到产品的含量。 如果含量这一项不是必检项目,那么http://CRS.edqm.eu上、标签上、或相关单页上都不会标出含量,这种情况下,我们不能把此标准品当作100%做定量检测。但是,当一个杂质标准品被用于相关物质的控制杂质含量检测时,在产品标签上或http://CRS.edqm.eu 没有标明产品的含量下,我们也可以把它当作100%含量。

 

其他EP常见问题可参见:http://www.edqm.eu/en/page_630.php?rubrique=175

 

关于USP常见问题可参见:http://www.usp.org/ZH/referenceStandards/faq.html
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