Back 4 new Ph. Eur. reference standard and 19 replacement batches released in July 2024

EDQM Strasbourg, France 01/08/2024
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4 new Ph. Eur. reference standard and 19 replacement batches released in July 2024

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

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

Catalogue code

Name

Unit quantity

Price

Y0002346

Golimumab CRS

10 MG

150 EUR

Y0002454

Ursodoxicoltaurine dihydrate CRS

25 MG

79 EUR

Y0002483

Atorvastatin for peak identification C CRS

15 MG

79 EUR

Y0002446

Ursodoxicoltaurine impurity A CRS

25 MG

79 EUR

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0001675

Meldonium impurity E CRS

2

25 MG

79 EUR

Y0001434

Montelukast sodium CRS

2

15 MG

79 EUR

Y0000608

Bisacodyl for peak identification CRS

2

15 MG

79 EUR

Y0000099

Pentoxyverine impurity B CRS

2

15 MG

79 EUR

I0329000

Iopamidol CRS

2

50 MG

79 EUR

Y0001889

Benzylpenicillin for system suitability CRS

2

10 MG

79 EUR

Y0000335

Flumazenil impurity B CRS

3

5 MG

79 EUR

A1330000

Aspartic acid CRS

3

50 MG

79 EUR

Y0001314

1-nonadecanol CRS

4

425 MG

79 EUR

P2155010

Plastic additive 10 CRS

4

260 MG

79 EUR

K0551000

Ketamine impurity A CRS

4

20 MG

79 EUR

B0100000

Bacitracin zinc CRS

4

150 MG

79 EUR

Y0001494

Hydrochlorothiazide for peak identification CRS

5

15 MG

79 EUR

M1750000

Methylprednisolone CRS

5

100 MG

79 EUR

C2163000

Ciclosporin CRS

5

100 MG

79 EUR

Y0001544

Insulin glargine for peak identification CRS

5

3.2 MG

79 EUR

D3000000

Doxycycline hyclate CRS

7

50 MG

79 EUR

B1220000

Ibuprofen impurity B CRS

11

1.15 ML

79 EUR

Y0000641

Azithromycin for system suitability CRS

13

0.05 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 30/06/2024. The reference will remain visible in the catalogue until 31/12/2024.

  • Supplement 11.4

Following the implementation of Supplement 11.4, the following standards are officially withdrawn (or replaced) from 1st April 2024.

S2400004

Suxibuzone impurity B CRS

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1st October 2024. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1st 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)

  • Supplement 11.5

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

C2320000

Clomifene citrate CRS

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1st January 2025. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1st 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.

Information on reference standards with a future removal from catalogue

  • Supplement 11.6

Following the implementation of Supplement 11.6, the following standard will be officially withdrawn (or replaced) from 1st January 2025

Catalogue code

Name

 

Y0000289

Polysorbate 20 - reference spectrum

Will be replaced by a CRS

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 July 2025. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 January 2026) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0000290

Polysorbate 40 - reference spectrum

Will be replaced by a CRS

Y0000291

Polysorbate 60 - reference spectrum

Will be replaced by a CRS

P0309020

Pefloxacin impurity B

P0309030

Pefloxacin impurity C

N1230010

Norfloxacin impurity A

Y0002319

Atorvastatin for peak identification A CRS

Y0002327

Ciprofibrate for system suitability A CRS will be replaced by Ciprofibrate for system suitability B CRS (Y0002450)

Y0002197

Deferasirox for system suitability will be replaced by Deferasirox for system suitability A (Y0002456)

I0600000

Isoprenaline sulfate

P1255100

Phenylmercuric borate - reference spectrum

Y0001463

Actaea racemosa HRS

Y0001958

Colchicine for system suitability A will be replaced by Colchicine for system suitability B (Y0002460)

Change of sales units

  • The sales unit of Plastic additive 27 CRS (Y0002024) has been changed from 1 to 2 units. The quantity per vial is sufficient to perform the test mentioned in Ph. Eur. monograph 30302, 30303, 30305.

Information on change of amount per unit

  • Pentoxyverine impurity B CRS (Y0000099) batch 2 contains 15 mg per unit (10 mg previously)
  • Bisacodyl for peak identification CRS (Y0000608) batch 2 contains 15 mg per unit (10 mg previously)
  • Methylprednisolone CRS (M1750000) batch 5 contains 100 mg per unit (240 mg previously)
  • Azithromycin for system suitability CRS (Y0000641) batch 13 contains 0.05 mg per unit (1 mg previously)
  • Montelukast sodium CRS (Y0001434) batch 3 contains 15 mg per unit (20 mg previously)
  • Hydrochlorothiazide for peak identification CRS (Y0001494) batch 5 contains 15 mg per unit (10 mg previously)
  • Plastic additive 10 CRS (P2155010) batch 4 contains 260 mg per unit (250 mg previously)

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