• New releases:
  • New Ph. Eur. reference standards
  • Replacement batches for Ph. Eur. reference standards
• Removal
• Future removal
• Change of sales units
• Change of EDQM storage/shipping conditions
• Change in the policy for withdrawing reference standards from sale

Information for Indian users

Shipments to China

• Current non-availability

See also:

Content of the Ph. Eur. RS catalogue
How to place an RS order

The EDQM announces the availability of:

• 1 new European Pharmacopoeia (Ph. Eur.) reference standard:

• 29 replacement batches for Ph. Eur. reference standards:

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Information on reference standards removed from catalogue

• 01/01/2020

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Information on reference standards with a future removal from catalogue

• 01/04/2020

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• 02/07/2021

Information on change of sales units

None.

Information on change of EDQM storage/shipping conditions

In order to ensure better stability, storage and shipping conditions have been changed for the following reference standard from 15/01/2020:

Enalapril impurity mixture A CRS batch 2 is stored at –20 °C and shipped at +5 °C.

Change in the policy for withdrawing reference standards from sale

A new policy will be applied from the application of Supplement 10.2 (01/07/2020). Detailed information is available in the news item of 24 January 2020.

 Information for Indian users: shipment of Oxytocin CRS to India

The Ministry of Health and Family Welfare of India has lifted the ban on Oxytocin reference standards imported exclusively for the purpose of test and analysis.

The EDQM is therefore now in a position to ship Oxytocin CRS and Oxytocin/Desmopressin validation mixture CRS (catalogue code O0700000 and O0770000) to India once again.

 Shipments to China

The shipping company working with the EDQM has cancelled all its flights to Beijing and Shanghai until 28/02/2020. As the situation may change quickly, we will inform our users as soon as possible via the EDQM web page.

Information on the current non-availability of a reference standard

Ph. Eur. Somatropin/Desamidosomatropin resolution mixture CRS (Y0000711) is currently unavailable.

To overcome the temporary shortage of this CRS and until the replacement batch is made available, it is advised to prepare the system suitability resolution solution for the test of related proteins described in the monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin) and 0952 (Somatropin for injection) by using the Ph. Eur. Somatropin CRS Batch 3 (Cat. No. S0947000).

See more information in the Note to users.

Content of the European Pharmacopoeia RS catalogue

The EDQM proposes more than 3000 Ph. Eur. RS, including a wide range of highly characterised chemical reference substances (CRS), herbal reference standards (HRS) and biological reference preparations (BRP), as well as reference spectra for the tests and assays to be carried out in accordance with the official methods prescribed in the Ph. Eur. The Ph. Eur. RS catalogue is updated on a daily basis and gives access not only to all the Ph. Eur. RS, but also to:

• Batch Validity Statements (BVSs) for each reference standard;

• Safety Data Sheets and Safety Data Statements for hazardous biologicals;
• leaflets (downloadable PDFs).

For your convenience, the Ph. Eur. RS catalogue is published on a daily basis and can be downloaded in PDF format and in XML format.

How to place an RS order

If you wish to place an order, you can send your request to the EDQM either:

• via the web store (this form can also be used to confirm a proforma invoice or a quotation you have already received from the EDQM);

• or by e-mail to [email protected] (in this case, please ensure that your order, on your company letterhead, states both the catalogue code and substance name and is attached to your e-mail).

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