Back 8 new Ph. Eur. reference standard and 18 replacement batches released in June 2024

EDQM Strasbourg, France 02/07/2024
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8 new Ph. Eur. reference standard and 18 replacement batches released in June 2024

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

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

Catalogue code

Name

Unit quantity

Price

Y0002456

Deferasirox for system suitability A CRS

0.502 MG

79 EUR

Y0002452

Mercaptopurine monohydrate CRS

15 MG

79 EUR

Y0002461

Pefloxacin for system suitability CRS

1.001 MG

79 EUR

Y0002172

Tilidine for system suitability CRS - * narc (Tilidine hydrochloride hemihydrate

10 MG

79 EUR

Y0002448

Chloroquine phosphate for peak identification CRS

15 MG

79 EUR

Y0002451

Chloroquine phosphate impurity C CRS

15 MG

79 EUR

Y0002453

Taurine CRS

15 MG

79 EUR

Y0002449

Ursodoxicoltaurine for impurity B identification CRS

10 MG

79 EUR

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0000813

Bisoprolol for system suitability CRS

6

1.003 MG

79 EUR

A1400000

Atropine sulfate CRS

5

20 MG

79 EUR

C2600000

Colistimethate sodium CRS

4

26.2 MG

79 EUR

Y0000401

Pimobendan for system suitability CRS

3

0.1 MG

79 EUR

Y0001766

Cisatracurium besilate CRS

3

130 MG

79 EUR

Y0001577

Isoprenaline impurity A CRS

3

15 MG

79 EUR

H1450000

Hyoscine butylbromide CRS

3

20 MG

79 EUR

Y0001681

Prilocaine for peak identification CRS

3

20 MG

79 EUR

Y0001665

Progesterone for system suitability CRS

3

5 MG

79 EUR

Y0001047

Teicoplanin for identification CRS

3

50 MG

79 EUR

Y0001825

Aprepitant CRS

2

150 MG

79 EUR

Y0001674

Meldonium impurity D CRS

2

25 MG

79 EUR

Y0002076

Asparagine impurity C CRS

2

15 MG

79 EUR

Y0002272

Bisacodyl for system suitability A CRS

2

10 MG

79 EUR

Y0001705

Eplerenone for system suitability CRS

2

10 MG

79 EUR

Y0002266

Zidovudine for system suitability A CRS

2

15 MG

79 EUR

Y0001313

Testosterone enantate impurity H CRS

2

15 MG

79 EUR

Y0002235

Piperacillin For Peak Identification CRS

2

15 MG

79 EUR

  • 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

  • Additional removal from catalogue

Catalogue code

Name

 

I0305000

Insulin (bovine) CRS

This reference standard is officially withdrawn from sale on 30 June 2024. The reference will remain visible in the catalogue until 31 December 2024.

  • Supplement 11.4

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

S2400004

Suxibuzone impurity B CRS

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 October 2024. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 April 2025) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

T0040000

Temazepam CRS - * psy

Y0000346

Temazepam impurity F CRS

Y0000344

Temazepam impurity C CRS

Y0000345

Temazepam impurity D CRS

Y0000347

Temazepam impurity G CRS

Y0002071

Calcium folinate for system suitability CRS (replaced by calcium folinate for system suitability A CRS)

Information on reference standards with a future removal from catalogue

  • Supplement 11.5

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

C2320000

Clomifene citrate CRS

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 January 2025. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 July 2025) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Change of sales units

  • None

Information on change of amount per unit

  • Testosterone enantate impurity H CRS (Y0001313) batch 2 contains 15 mg per unit (10 mg previously)
  • Asparagine impurity C CRS (Y0002076) batch 2 contains 15 mg per unit (10 mg previously)
  • Zidovudine for system suitability A CRS (Y0002266) batch 2 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 June 2024 for the following reference standard:

  • Captopril impurity J CRS (Y0001450) batch 3 is stored at -20°C (previously +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

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 users 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.