null 1 new Ph. Eur. reference standards and 13 replacement batches released in December 2022

EDQM Strasbourg, France 02/01/2023
1 new Ph. Eur. reference standards and 13 replacement batches released in December 2022

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

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

Catalogue code

Name

Unit quantity

Price

Y0002382

Propylene glycol monocaprylate type 1

600 mg

79 EUR

 

 

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

Catalogue code

Name

Batch

Unit quantity

Price

C2970000

Crotamiton CRS

4

180 mg

79 EUR

G0200000

Gentamicin sulfate CRS

15

25 mg

79 EUR

Y0001170

Ascorbic acid impurity D CRS

4

15 mg

79 EUR

Y0001012

Ginkgo dry extract for peak identification CRS

3

150 mg

79 EUR

A0325000

Alanine CRS

4

60 mg

79 EUR

Y0000424

Atracurium besilate CRS

5

120 mg

79 EUR

Y0002081

Moxifloxacin for peak identification B CRS

2

10 mg

79 EUR

I0465000

Isomalt CRS

6

600 mg

79 EUR

Y0001968

Fipronil CRS

2

180 mg

79 EUR

Y0000096

Mesterolone impurity A CRS

2

40 mg

79 EUR

Y0000676

Gemcitabine impurity A CRS

2

25 mg

79 EUR

Y0000881

Ibuprofen for peak identification CRS

11

0.09 mg

79 EUR

Y0000682

Noradrenaline impurity E CRS

2

15 mg

79 EUR

 

Information on reference standards removed from catalogue

  • 11th edition

Following the implementation of the 11th edition, the following standards are officially withdrawn (or replaced) from 1 January 2023.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

 

Information on reference standards with a future removal from catalogue

  • Supplement 11.1

Following the implementation of Supplement 11.1, the following standards will be officially withdrawn (or 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

  • Crotamiton (C2970000): 1 vial per sales unit for batch 4 instead of 2 for batch 3.

 

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 15/12/2022 for the following reference standard:

  • Piperacillin impurity N (Y0002241) CRS batch 1 is stored at -20 °C (previously +5 °C) and shipped on Ice -20 °C (previously at ambient condition).

 

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.