• 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
• Current non-availability

See also:

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

The EDQM announces the availability of:

• 14 New Ph. Eur. reference standards:

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• 18 Replacement batches for Ph. Eur. reference standards:

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Information on reference standards removed from catalogue
 

• 02/07/2021

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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Following the implementation of Supplement 10.3, the following standards are officially withdrawn as of 01 January 2021.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:

Fluoxetine impurity B CRS – F0253020 – changed from 1 to 3 vials.

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Information on change of price:

Please note that Everolimus CRS, Everolimus for system suitability CRS and Everolimus for impurity C identification CRS Batch 2 will be sold €300.

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Information on change of EDQM storage / shipping conditions:

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

• Benzathine benzylpenicillin for peak identification CRS batch 1 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 with immediate effect for the following reference standard:

• Cefepime dihydrochloride monohydrate for system suitablity CRS batch 3 is now stored at –20°C (previously +5°C) and shipped under Ice –20°C (previously ambient temperature).

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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).

See 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. 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 European Pharmacopoeia (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 pdf).

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

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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 is on your company letter headed paper stating both the catalogue code and substance name and attached to your email).

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