• New Ph. Eur. reference standards
• Replacement batches for Ph. Eur. reference standards
• Removal
• Future removal
• Change of sales units
• Technical information
• 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 European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the release of:

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

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

Information on reference standards removed from catalogue

• Supplement 10.8

Following the implementation of Supplement 10.8, the following standards are officially withdrawn from 1 July 2022.

Information on reference standards with a future removal from catalogue

• 11th edition

Following the implementation of the 11th edition, the following standards will be officially withdrawn (replaced) from 1 January 2023.

• Supplement 11.1

Following the implementation of the Supplement 11.1, the following standards will be officially withdrawn (replaced) from 1 January 2023.

Information on change of sales units

• None

Technical information

• Cholecalciferol for system suitability CRS

Due to quality issue, the distribution of Cholecalciferol for system suitability CRS 11 has been suspended. Users still having the CRS may nevertheless use it.

Cholecalciferol for system suitability CRS is referred to in 3 monographs:

• Ph. Eur. monograph 0072 for Cholecalciferol
• Ph. Eur. monograph 0575 for Cholecalciferol concentrate (oily form)
• Ph. Eur. monograph 0574 for Cholecalciferol concentrate (powder form)

Revised versions of the monographs have been published in the 11th Edition – implementation date: 1 January 2023.

In these revised monographs, Cholecalciferol for system suitability CRS is replaced by a preparation composed of Cholecalciferol CRS and Cholecalciferol impurity A CRS.

Users are advised to immediately implement the revised versions of the monographs. A copy of the latter can be provided to users upon request.

• Marbofloxacin impurity mixture CRS

Marbofloxacin impurity mixture CRS (Y0002317) will be suppressed on 1 January 2023 and replaced by Marbofloxacin impurity mixture A CRS (Y0002380).

Marbofloxacin impurity mixture CRS is used in monograph 2233 (Marbofloxacin for veterinary use).

A revised version of this monograph has been published in the 11th Edition – implementation date: 1 January 2023.

Unfortunately, the stock of Marbofloxacin impurity mixture CRS is exhausted and therefore users are advised to immediately implement the revised version of the monograph. A copy of the latter can be provided to users upon request.

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, storage and shipping conditions will be changed on 15 November 2022 for the following reference standard:

• Beta-sitosterol for peak identification (Y0002268) CRS batch 1 will be stored at +5°C (previously –20°C) and at ambient condition (previously Ice –20°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 quantities allowed in case of sales restrictions now appear in the online catalogue as well as in the catalogue 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 WebStore;
• 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).

A video has been prepared to help user ordering through the RS WebStore.