• New Ph. Eur. reference standards
• Replacement batches for Ph. Eur. reference standards
• Removal
• Future removal
• Change of sales units
• Information on change of price
• Change of EDQM storage/shipping conditions

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 standards:

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

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Information on reference standards removed from catalogue

• Supplement 10.3

Following the implementation of Supplement 10.3, the following standards are officially withdrawn from 1 January 2021.

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• Supplement 10.4

Following the implementation of Supplement 10.4, the following standards are officially withdrawn from 1 April 2021.

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Information on reference standards with a future removal from catalogue

• Supplement 10.5

Following the implementation of Supplement 10.5 (1 July 2021), the following standards will be removed from the catalogue:

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The following standards will also be removed and replaced:

NB These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of December 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 30 June 2022) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Information on change of sales units

None.

Information on change of price

Please note the price change for Batch 2 of Everolimus CRS and Everolimus for impurity C identification CRS, to €300 per sales unit.

Information on change of EDQM storage/shipping conditions

Based on new stability information, shipping conditions were simplified on 15 March 2021 for the following reference standards:

• Omeprazole for peak identification (Y0001042) CRS batch 2 is shipped at ambient temperature (previously Ice –20°C);
• Biotin for system suitability (Y0001978) CRS batch 1 is shipped at ambient temperature (previously Ice –20°C);
• Colistin for system suitability (Y0001999) CRS batch 1 is shipped at ambient temperature (previously Ice –20°C).

In order to ensure better stability, shipping conditions were changed on 15 March 2021 for the following reference standard:

• Enalapril impurity A mixture CRS (Y0001853) batch 2 is shipped under Ice –20 °C (previously Ice +5°C).

Content of the European Pharmacopoeia RS catalogue

The EDQM proposes more than 3 000 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 daily and can be downloaded in in PDF format and in XML format.

When stocks of a given reference standard are low, the EDQM reserves the right to limit the quantities sold to each user to ensure that as many users as possible will receive at least some of the quantities available. Restrictions on quantities are applied at the time the purchase order is received.

Following a request from many users, the quantity allowed for each user is now directly displayed in the detailed view of the online catalogue.

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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