• Replacement batches for Ph. Eur. reference standards
• Information on reference standards removed from catalogue
• Information on reference standards with a future removal from catalogue
• Change of sales units / price
• Information on change of amount per unit
• Change of EDQM storage/shipping conditions
• Information on International Chemical Reference Substances (ICRS) and International Standards for Antibiotics (ISA)

See also:

• Content of the Ph. Eur. RS catalogue
• How to place an RS order
• The EDQM helps the users to test some draft texts proposed in Pharmeuropa through Qualified Samples

The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the release of:

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

Information on reference standards removed from catalogue

• 11th edition

Following the implementation of the 11th edition, the following standards are officially withdrawn (or replaced) from 1 January 2023.

Information on reference standards with a future removal from catalogue

• Supplement 11.1

Following the implementation of Supplement 11.1, the following standards are officially withdrawn (or replaced) from 1 April 2023.

• Supplement 11.2

Following the implementation of Supplement 11.2, the following standards will be officially withdrawn (or replaced) from 1 July 2023.

Information on change of sales units / price

• The sales unit of H1100000 Human rabies Ig BRP will be changed from 3 to 1 unit and the price will change from 90€ to 79€ from 15/06/2023. The quantity is sufficient to perform the test mentioned in Ph. Eur. monograph 0723. The sales restriction will also be lifted on 15/06/2023.

Information on change of amount per unit

• Sodium aminosalicylate dihydrate (Y0001669) CRS batch 1.1 contains 20 mg per unit (previously 10 mg)
• Mepyramine impurity C CRS batch 2 contains 15 mg per unit (previously 10 mg)
• Progesterone for impurity H identification CRS batch 4 contains 25 mg per unit (previously 20 mg)

Information on change of EDQM storage/shipping conditions

Based on new stability information, storage and shipping conditions have been changed on 15 June 2023 for the following reference standard:

• Cladribine impurity C (Y0000610) CRS batch 1 is stored at +5°C (previously -20°C) and shipped at ambient temperature (previously on ice at -20°C)

Corrigendum:

• Since 15 April 2023, 1,1'-Ethylidenebistryptophan (E2205500) CRS batch 9 is stored at -20 °C and shipped at ambient temperature (instead of on ice at -20°C as stated in previous Newsletter).

Information on International Chemical Reference Substances (ICRS) and International Standards for Antibiotics (ISA)

ICRS

• None

ISA

• None

Content of the European Pharmacopoeia RS catalogue

The EDQM proposes more than 3 100 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.

The EDQM is also responsible for the establishment, preparation, storage and distribution of WHO International Chemical Reference Standards (ICRS) and International Standards for Antibiotics (ISA).

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.

The EDQM helps the users to test some draft texts proposed in Pharmeuropa through Qualified Samples

In some cases, ‘qualified samples’ are made available by the EDQM at the time of publication in Pharmeuropa to allow users to check the changes (e.g. to the related substances test) proposed during the public enquiry and best prepare for the implementation of the monograph.

Where a qualified sample is available, it is described in the briefing note of the Pharmeuropa monograph and may be ordered free of charge by raising a request in the EDQM HelpDesk.

After use, users are kindly requested to share their results with the EDQM.

To place an order via the EDQM HelpDesk, please click on European Pharmacopoeia and choose the category Question about General Chapters and Monographs. Providing us with your full shipping address and the title of the corresponding Ph. Eur. monograph, while stating ‘Qualified sample’ in the subject of the query, will help us to rapidly process your request.

For further information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.