null 5 new Ph. Eur. reference standards and 12 replacement batches released in November 2022

EDQM Strasbourg, France 06/12/2022
5 new Ph. Eur. reference standards and 12 replacement batches released in November 2022

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

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

Catalogue code

Name

Unit quantity

Price

Y0002345

Pulsatilla root for system suitability HRS

210 mg

100 EUR

Y0002355

Valganciclovir for system suitability CRS

0.204 mg

79 EUR

Y0002378

Mirabegron impurity G CRS

15 mg

79 EUR

Y0002349

Prim-O-glucosylcimifugin CRS

20 mg

79 EUR

Y0002350

Pulchinenoside B4 CRS

30 mg

79 EUR

 

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0001158

Melphalan hydrochloride CRS

3

110 mg

79 EUR

Y0001060

Benzalkonium chloride for system suitability CRS

6

20 mg

79 EUR

Y0001105

Drospirenone CRS

3

80 mg

79 EUR

Y0000256

Paroxetine impurity D CRS

4

10 mg

79 EUR

Y0001724

Agnus castus fruit dry extract HRS

2

350 mg

79 EUR

Y0001950

Phosphatidylcholine from soya bean CRS

2

200 mg

79 EUR

M1800900

Methylthioninium chloride CRS

3

130 mg

79 EUR

Y0002347

Saposhnikovia root for system suitability HRS

2

510 mg

79 EUR

T1985000

Trichlorotrifluoroethane CRS - * ODS

2

2.5 mL

79 EUR

F0250000

Fluorouracil CRS

4

35 mg

79 EUR

Y0000757

Riboflavin for peak identification CRS

5

0.12 mg

79 EUR

Y0001342

Sucralose impurity B CRS

4

0.5 mg

79 EUR

 

Information on reference standards removed from catalogue

  • Supplement 10.8

Following the implementation of Supplement 10.8, the following standards are officially withdrawn from 1 July 2022.

Y0000645

Bromazepam for system suitability

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 January 2023. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 July 2023) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0001005

Dydrogesterone impurity A

 

Information on reference standards with a future removal from catalogue

  • 11th Edition

Following the implementation of the 11th Edition, the following standards will be officially withdrawn (replaced) from 1 January 2023.

D0120000

Daunorubicinone

(replaced by  Daunorubicin for system suitability Y0002351)

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 July 2023. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 January 2024) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0000768

Etodolac for peak identification

(replaced by Etodolac impurity mixture Y0002335)

Y0000363

Ciprofibrate for system suitability

(replaced by  Ciprofibrate for system suitability A Y00002327)

D0431000

Dequalinium chloride for performance test

(replaced by Dequalinium for system suitability Y00002333)

D0430000

Dequalinium chloride

(replaced by Dequalinium chloride for ID Y00002332)

M1550000

Methylene chloride

(replaced by Methylene chloride - reference spectrum Y00002337)

Y0002317

Marbofloxacin impurity mixture

(replaced by Marbofloxacin impurity mixture A)

C2150000

Cholecalciferol for system suitability

 

  • Supplement 11.1

Following the implementation of Supplement 11.1, the following standards will be officially withdrawn (replaced) from 1 April 2023.

Y0001245

Amylmetacresol for peak identification

(remplaced by Amylmetacresol for peak identification A Y0002370)

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 October 2023. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 April 2024) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

 

Y0000264

Diclazuril for veterinary use - reference spectrum          (remplaced by Diclazuril Y0002342)

Y0000748

Tibolone - reference spectrum (remplaced by Tibolone Y0002348)

D1500000

Diethylstilbestrol

D1600000

Diethylstilbestrol dimethyl ether

D1700000

Diethylstilbestrol monomethyl ether

Y0002061

Everolimus for system suitability                      (remplaced by Everolimus for system suitability A Y0002354)

 

Information on change of sales units

  • None.

Technical information

  • Cholecalciferol for system suitability CRS

Due to quality issue, the distribution of Cholecalciferol for system suitability CRS 11 has been suspended. Users still having the CRS may nevertheless use it.

Cholecalciferol for system suitability CRS is referred to in 3 monographs:

  • Ph. Eur. monograph 0072 for Cholecalciferol
  • Ph. Eur. monograph 0575 for Cholecalciferol concentrate (oily form)
  • Ph. Eur. monograph 0574 for Cholecalciferol concentrate (powder form)

Revised versions of the monographs have been published in the 11th Edition – implementation date: 1 January 2023.

In these revised monographs, Cholecalciferol for system suitability CRS is replaced by a preparation composed of Cholecalciferol CRS and Cholecalciferol impurity A CRS.

Users are advised to immediately implement the revised versions of the monographs. A copy of the latter can be provided to users upon request.

  • Marbofloxacin impurity mixture CRS

Marbofloxacin impurity mixture CRS (Y0002317) will be suppressed on 01/01/2023 and replaced by Marbofloxacin impurity mixture A CRS (Y0002380).

Marbofloxacin impurity mixture CRS is used in monograph 2233 (marbofloxacin for veterinary use).

A revised version of this monograph has been published in the 11th Edition – implementation date: 1 January 2023.

Unfortunately, the stock of Marbofloxacin impurity mixture CRS is exhausted and therefore users are advised to immediately implement the revised version of the monograph. A copy of the latter can be provided to users upon request.

Information on change of price

Please note the price change for batch 2 of Everolimus CRS and Everolimus for impurity C identification CRS, to €300 per sales unit.

Information on change of EDQM storage/shipping conditions

Based on new stability information, storage and shipping conditions have been changed on 15 November 2022 for the following reference standard:

  • Beta-sitosterol for peak identification (Y0002268) CRS batch 1 is stored at +5 °C (previously –20 °C) and shipped at ambient condition (previously Ice –20 °C).

Content of the European Pharmacopoeia RS catalogue

The EDQM proposes more than 3 000 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.

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 orders@edqm.eu (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.