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

See also:

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

The EDQM announces the availability of:

• 7 new European Pharmacopoeia (Ph. Eur.) reference standards:

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

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Information on reference standards removed from catalogue

None.

Information on reference standards with a future removal from catalogue

• 02/07/2021

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Information on change of sales units

None.

Information on change of price

Please note that the price for Everolimus CRS, Everolimus for system suitability CRS and Everolimus for impurity C identification CRS Batch 2 has changed to €300.

Information on change of EDQM storage/shipping conditions

Based on new stability information, storage and shipping conditions will be simplified on 15/06/2020 for the following reference standards:

• Nilotinib for system suitability CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C);
• Nilotinib impurity A CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C);
• Nilotinib impurity B CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C);
• Nilotinib impurity C CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C);
• Simvastatin for system suitability CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C).

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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 on the current non-availability of a reference standard

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

In order 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).

Find more information in the Note to users.

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Content of the European Pharmacopoeia RS catalogue

The EDQM proposes more than 3 000 Ph. Eur. RSs, 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. RSs, but also to:

• Batch Validity Statements (BVSs) for each reference standard;
• Safety Data Sheets and Safety Data Statements for hazardous biologicals;
• leaflets (downloadable as 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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