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USP, EP standard use FAQs
View: 546  Form: JZSW  Date: 2015-04-15

 USP, EP standard use FAQs

                                                  
, EP Frequently Asked Questions
The double labeling issues, EP website http://www.edqm.eu/site/EDQM_Reference_Standards-649.html search, the following information:
 
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
 
New label
EDQM will take all standard packaging bottles posts on the double label, most of the products have been replaced with double label, but there are a few parts have not been posted to, or a single label. Paste Duplex pins purpose is to facilitate the user when doing experiments (in particular, when the authentication is done) affixed to the outside layer of pins peeled in Experimental written record to confirm that the source of this item.
 
2 small batches of the problem can be on the EP website http://www.edqm.eu/site/page_630.php?rubrique=180 query, the following information:
 
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.
 
In the specific case, due to the filling and labeling, small batches (such as 1.1, 1.2, 1.3, etc.) are from the same batch of packaging bulk drugs proposed. Please note: the call before small batch classification by 1a, 1b, 1c ... gradually changed to 1.1, 1.2, 1.3 ... However, all necessary precautions must follow the instructions to ensure that small batches of standard quality and specifications do not differ from each other.
 
3. Purity problem:
 
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.
 
Can be found from the http://CRS.edqm.eu content. If the content is not always checked items http://CRS.edqm.eu on the label, or on a single page will not be marked on the content of this case, we can not put this standard as 100% quantitative detection. However, when an impurity standard is used for the detection of related substances control impurities on product labels or http://CRS.edqm.eu not marked on the content of the products, we can also take it as 100% content.
 
Other EP Frequently Asked Questions can be found in: http://www.edqm.eu/en/page_630.php?rubrique=175
 
, USP Frequently Asked Questions
USP Frequently Asked Questions can be found in: http://www.usp.org/ZH/referenceStandards/faq.html
 
 
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