• New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards
• Distribution quota
• Removal
• Future removal
• Change of sales units
• Information on change of amount per unit
• Information on change of price
• Change of EDQM storage/shipping conditions
• Information on International Chemical Reference Substances (ICRS) and International Standards for Antibiotics (ISA)
• Rules about Substances depleting the ozone layer

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:

5 new European Pharmacopoeia (Ph. Eur.) reference standards:

13 replacement batches for Ph. Eur. reference standards:

Distribution quota

Information on distribution quota for Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (Y0001689)

Due to premature depletion of stocks of the Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689), we wish to inform users that a tight distribution quota has been established.

This BRP will be distributed to plasma-derived therapeutic product manufacturers and Official Medicines Control Laboratories only, with a maximum of 1 unit per month. This quota may be adjusted according to availability.

This exceptional measure will remain in place until the next batch of this BRP is established, which is expected by the end of 2024.

Distribution of the Immunoglobulin for anti-A, anti-B antibodies limit test BRP (cat. # Y0001153) and the Immunoglobulin (anti-A, anti-B antibodies test Positive control) BRP (cat. # Y0001688) is not affected by this measure.

We apologise for any inconvenience caused and thank you for your understanding.

Information on reference standards removed from catalogue

Supplement 11.3

Following the implementation of Supplement 11.3, the following standards are officially withdrawn (or replaced) from 1 January 2024.

Information on reference standards with a future removal from catalogue

Additional removal from catalogue

Supplement 11.4

Following the implementation of Supplement 11.4, the following standards will be officially withdrawn (or replaced) from 1^st April 2024.

Supplement 11.5

Following the implementation of Supplement 11.5, the following standard will be officially withdrawn (or replaced) from 1^st July 2024.

Change of sales units

The sales unit of Esculin CRS (Y0001612) has been changed from 1 to 2 units. The quantity per vial is sufficient to perform the test mentioned in Ph. Eur. monograph 2452 and 2945.

Information on change of amount per unit

• Thiamazole impurity A CRS (Y0000372) batch 2 contains 50 mg per unit (15 mg previously)
• Febantel CRS (Y0000556) batch 4 contains 120 mg per unit (150 mg previously)
• Gemcitabine hydrochloride CRS (Y0000675) batch 3 contains 60 mg per unit (50 mg previously)
• Ephedrine hydrochloride CRS - * Drug Precursor (E0300000) batch 4 contains 160 mg per unit (150 mg previously)
• Diosmin for system suitability CRS (Y0000095) batch 4 contains 15 mg per unit (10 mg previously)

Information on change of price

None

Information on change of EDQM storage/shipping conditions

Based on new stability information, storage and shipping conditions has been changed on 15 May 2024 for the following reference standard:

• Heparin LMM for calibration CRS (H0190000) batch 6 is stored at -20°C (previously +5°C) and shipped on ice at -20°C (previously +5°C).
• Betacarotene CRS (Y0002050) batch 4 is stored at -20°C (previously +5°C) and shipped on ice at -20°C (previously ambiant).
• Betacarotene for system suitability CRS (Y0002073) batch 1 is stored at -20°C (previously +5°C) and shipped on ice at -20°C (previously ambiant).

Based on new stability information, storage and shipping conditions will change on 15 June 2024 for the following reference standard:

• Captopril impurity J CRS (Y0001450) batch 3 will be stored at -20°C (currently +5°C) and remain shipped at ambient temperature.

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

ICRS

• None

ISA

• None

Rules about Substances depleting the ozone layer

Regulation (EU) 2024/590 on substances that deplete the ozone layer entered into force on 11 March 2024. The rules governing the placing on the market and use of ozone-depleting substances for essential laboratory and analytical uses have now changed.

Under the new regulation, standards shipped to a location within the European Union no longer need to be registered in the labODS registry.

There is no change to the procedure for shipments outside the European Union.

The EDQM Reference Standards affected by this change are:

Important notes:

In all cases, these Reference Standards supplied by the EDQM must be used exclusively for essential laboratory and analytical uses (i.e. for analytical uses in conjunction with the texts published in the European Pharmacopoeia).

We would also like to draw your attention to the obligations of users affected by this change that are described under Article 8(4) of this regulation.

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.