EDQM REFERENCE STANDARDS
09 August 2013
The European Pharmacopoeia (Ph. Eur.) Commission has adopted two new Biological Reference Preparation (BRP) one for the assay of the lipolytic activity and another for the assay of the amylolytic activity according to the Ph. Eur. monograph 0350 (Pancreas powder). The two Reference Standards replace the Pancreas powder (amylase and lipase) BRP. The revised monograph 0350 will be published in the supplement 8.2. of the Ph. Eur. Meanwhile all required information are available in the leaflet and in the CRS database.
18 July 2013
The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new Biological Reference Preparation (BRP) for the assay of Hepatitis B immunoglobulin products according to the Ph. Eur. monographs 0722 (Human Hepatitis B immunoglobulin) and 1016 (Human Hepatitis B immunoglobulin for intravenous administration). The new Human Hepatitis B immunoglobulin BRP batch 1 is available on the EDQM website under catalogue reference Y0001414.
The Reference Standards Catalogue lists all the reference standards officially valid for the uses prescribed in the European Pharmacopoeia monographs. It gives a list of newly adopted standards, a Batch Validity Statement (BVS) for reference standards, 2687 Safety Data Sheets, and 1386 leaflets are available to download. It is updated daily in English only.
In order to ensure that reference to the EDQM Reference Standards is correctly reported, the EDQM would like to remind users that they have an obligation to ensure that any reference made to an EDQM Reference Standard in any publication, presentation or public document (ex. scientific articles, data sheets for kits) bears the exact name, and catalogue code of the Reference Standard and the exact name and address of EDQM as given by the EDQM on the label or in the official leaflet.
A list of new reference standards and new batches with the date of release is available. To read this list, simply click on 'New' when you enter the database.
You can place an order for reference standards using an online order form. To submit an order to the EDQM online, please fill in the online order form and click 'Submit Order'.
For more detailed instructions, please read 'How to order reference standards
Some customers have an additional form to fill in to accompany each CRS order:
Last update: 10 January 2014
For more information about Safety Data Sheets, please go to: