• New Ph. Eur. reference standards
• 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)

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:

• 1 new European Pharmacopoeia (Ph. Eur.) reference standard:

• 14 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 11.2

Following the implementation of Supplement 11.2, the following standards are officially withdrawn (or replaced) since 1 July 2023.

Information on reference standards with a future removal from catalogue

• Supplement 11.3

Following the implementation of Supplement 11.3, the following standards will be officially withdrawn (or replaced) from 1 January 2024.

Information on change of sales units

• None

Information on change of amount per unit

• Niflumic acid impurity A CRS (Y0000825) Batch 2: contains 20 mg per unit (previously 10 mg)
• Ondansetron impurity E CRS ( Y0001326) Batch 3: contains 15 mg per unit (previously 10 mg)
• Lacosamide impurity A CRS (Y0001972) Batch 2: contains 15 mg per unit (previously 5 mg)
• Milbemycin oxime CRS (Y0001893) Batch 2: contains 110 mg per unit (previously 100 mg)
• 4-Epitetracycline hydrochloride CRS (E0600000) Batch 10: contains 40 mg per unit (previously 30 mg)
• Dexpanthenol CRS (D0730000) Batch 7: contains 150 mg per unit (previously 20 mg)
• Ascorbic acid impurity C CRS (Y0001024) Batch 4: contains 30 mg per unit (previously 20 mg)
• Eplerenone CRS (Y0001704) Batch 2: contains 110 mg per unit (previously 75 mg)

Information on change of price

• None

Information on change of EDQM storage/shipping conditions

Based on new stability information, shipping conditions will change on 15 December 2023 for the following reference standards:

• Crotamiton for system suitability (Y0002338) CRS batch 1 is shipped at ambient temperature (previously on ice at -20°C) and stored at +5°C (previously -20°C).
• Crotamiton (C2970000) CRS batch 4 is shipped at ambient temperature (previously on ice at -20°C) and stored at +5°C (previously -20°C).
• Epirubicin hydrochloride (E0550000) CRS batch 7 is shipped at ambient temperature (previously on ice at -20°C) and stored at +5°C (previously -20°C).

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.