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USP,EP標準品使用常見問題
2018-11-05         
一、EP常見問題


1. 雙層標簽問題,可以上EP網站http://www.edqm.eu/site/EDQM_Reference_Standards-649.html 查詢,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

新標簽
EDQM將要把當前所有標準品的外包裝瓶上帖上雙層標簽,目前已經有大部分產品被換成雙層標簽了,但還有少數部分還沒被貼到,還是單層標簽。貼雙層標簽的目的是為了便于使用者在做實驗(特別是做認證時)時,把外面的一層標簽揭下來貼在所寫的實驗記錄中,以證實這個產品的來源。

2.小批次的問題,可以上EP網站http://www.edqm.eu/site/page_630.php?rubrique=180查詢,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.

在具體情況下,由于填裝和貼標等原因,小批次(比如1.1,1.2,1.3等)均是由同一批次的大包裝原料藥提出來的。請注意:之前小批次的分類稱呼將由1a,1b,1c...逐漸改為1.1,1.2,1.3...不過,所有必要的預防措施都必須按照指示進行以保證小批次的標準品的質量和規格不會彼此不同。

3.純度問題:

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 percent.

可以從http://CRS.edqm.eu 上查到產品的含量。 如果含量這一項不是必檢項目,那么http://CRS.edqm.eu上、標簽上、或相關單頁上都不會標出含量,這種情況下,我們不能把此標準品當作100%做定量檢測。但是,當一個雜質標準品被用于相關物質的控制雜質含量檢測時,在產品標簽上或http://CRS.edqm.eu上 沒有標明產品的含量下,我們也可以把它當作100%含量。

其他EP常見問題可參見:http://www.edqm.eu/en/page_630.php?rubrique=175



二、USP常見問題


關于USP常見問題可參見:http://www.usp.org/ZH/referenceStandards/faq.html

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