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

• 3 new European Pharmacopoeia (Ph. Eur.) reference standard

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

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Following the implementation of Supplement 11.2, the following standards are officially withdrawn (or replaced) since 1 July 2023.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Following the implementation of Supplement 11.3, the following standards will be officially withdrawn (or replaced) from 1 January 2024.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

• The sales unit of Desflurane impurity A (Y0000807) CRS has been changed from 2 to 1 unit. The quantity per vial is sufficient to perform the test mentioned in Ph. Eur. monograph 1666.

Information on change of amount per unit

• Oxcarbazepine (Y0001576) CRS batch 2 contains 130 mg per unit (previously 120 mg)
• Nilotinib for system suitability (Y0002100) batch 2 contains 15 mg per unit (previously 5 mg)
• Octyldodecanol (O0101000) CRS batch 6 contains 600 mg per unit (previously 500 mg)
• Desflurane impurity A (Y0000807) CRS batch 4 contains 1ml per unit (previously 0.5 ml)
• Nateglinide impurity A (Y0001440) CRS batch 2 contains 15 mg per unit (previously 10 mg)
• Ramipril impurity C (R0145015) CRS batch 4 contains 15 mg per unit (previously 10 mg)
• Chlordiazepoxide impurity A (Y0000476) CRS batch 3 contains 15 mg per unit (previously 10 mg)
• Ursodeoxycholic acid (U0800000) CRS batch 4 contains 90 mg per unit (previously 100 mg)
• Crotamiton impurity A (C297005) CRS batch 6 contains 70 mg per unit (previously 35 mg)
• Torasemide anhydrous (Y0000461) CRS batch 2 contains 30 mg per unit (previously 10 mg)
• Lisinopril for peak identification (Y0001701) CRS batch 1.1 contains 15 mg per unit (previously 10 mg)

Information on change of price

• None

Information on change of EDQM storage/shipping conditions

• None

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.