• 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:

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

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• 9 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

Following the implementation of Supplement 10.3, the following standards are officially withdrawn as of 1 January 2021.

These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of June 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 31 December 2021) to allow users to print the batch validity statement (BVS).

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Information on change of sales units

None.

Information on change of price

Please note the price change for Batch 2 of Everolimus CRS products, i.e. Everolimus for system suitability 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, storage and shipping conditions will be simplified on 15/12/2020 for the following reference standard:

• Catalpol CRS batch 2 will be stored at +5°C (previously -20°C) and shipped at ambient temperature (previously Ice -20°C).

In order to ensure better stability, storage and shipping conditions will be changed on 15/12/2020 for the following reference standards:

• Clotrimazole impurity E CRS batch 3 will be shipped under Ice +5 °C (previously ambient temperature) 
• Pregabalin impurity A CRS batch 2 will be stored at -20 °C (previously +5 °C) and shipped under Ice -20 °C (previously ambient temperature)

In order to ensure better stability, storage and shipping conditions have been changed for the following reference standards:

• Benzathine phenoxymethylpenicillin CRS batch 1 are now stored at -20 °C (previously +5 °C) and shipped under Ice -20 °C (previously ambient temperature)
• Benzathine phenoxymethylpenicillin for system suitability CRS batch 1 are now stored at -20 °C (previously +5 °C) and shipped under Ice -20 °C (previously ambient temperature)

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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.

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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