Council for europe portal
Language : en Search
Choose language

4 new Ph. Eur. reference standards and 21 replacement batches released in September 2021

Back
Reference Standard
Collection & Catalogue
News
08 October 2021
Strasbourg, France

See also:

 

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

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

Catalogue code

Name

Unit quantity

Price

Y0002308

Miconazole impurity G CRS

0.02 mg

79 EUR

Y0002301

Nebivolol impurity B CRS

0.003 mg

300 EUR

Y0002300

Nebivolol impurity D CRS

0.006 mg

300 EUR

Y0002309

Calcium carbonate for equipment qualification

260 mg

79 EUR

 

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0001052

Santonin CRS

2

20 mg

79 EUR

Y0000242

Glibenclamide impurity B CRS

4

15 mg

79 EUR

Y0001294

Iodixanol CRS

2

60 mg

79 EUR

Y0000638

Oxacillin sodium monohydrate CRS

2

130 mg

79 EUR

Y0001006

Dydrogesterone impurity B CRS

2

5 mg

79 EUR

Y0001747

Exemestane CRS

2

70 mg

79 EUR

M1650000

Methyl parahydroxybenzoate CRS

5

150 mg

79 EUR

Y0001774

Ropinirole impurity A CRS

2

25 mg

79 EUR

T1490000

Tinzaparin sodium CRS

2

250 mg

79 EUR

C0690500

Ceftazidime CRS

4

70 mg

79 EUR

Y0001129

Ganciclovir CRS

3

120 mg

79 EUR

I0320820

Iohexol impurity J CRS

2

125 mg

79 EUR

Y0001625

Salmeterol xinafoate for peak identification CRS

2

15 mg

79 EUR

E0900000

Ergocalciferol CRS

10

70 mg

79 EUR

C0465000

Carbimazole CRS

4

100 mg

79 EUR

Y0000789

Fexofenadine hydrochloride CRS

2

110 mg

79 EUR

Y0000695

Naloxone for peak identification CRS

4

5.1 mg

79 EUR

Y0001345

Ondansetron impurity A CRS

3

20 mg

79 EUR

Y0001346

Ondansetron impurity G CRS

3

10 mg

79 EUR

N0300000

Neamine CRS

8

0.5 mg

79 EUR

N1130000

Norcyclobenzaprine CRS

2

25 mg

79 EUR

 

Information on reference standards removed from catalogue

  • Supplement 10.5

Following the implementation of Supplement 10.5, the following standards are officially withdrawn from 1 July 2021.

D1750000

Diflunisal

These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of December 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 July 2022) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0000334

Codeine impurity A (O-methylcodeine)

Y0001641

Zidovudine for system suitability

Y0000361

Ciclosporin for system suitability

T0700000

Theobromine

 

Information on reference standards with a future removal from catalogue

  • Supplement 10.6

Following the implementation of Supplement 10.6 (1 January 2022), the following standards will be removed from the catalogue.

B0300000

Barbital

These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of June 2022. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 January 2023) to allow users to print the BVS. See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0000623

Terazosin impurity L

 

The following standards will also be removed and replaced.

Items removed

Catalogue code

Replaced by

Catalogue code

Bisacodyl for system suitability

Y0000694

Bisacodyl for system suitability A

Y0002272

Dipotassium clorazepate - reference spectrum

D2750100

Dipotassium clorazepate monohydrate CRS

Y0002276

Terazosin for system suitability

Y0000666

Terazosin for system suitability A CRS

Y0002286

Terazosin impurity A

Y0000622

Terazosin for system suitability A CRS

Y0002286

Nitrofural for peak identification

Y0001377

Nitrofural for peak indentification A CRS

Y0002295

Pravastatin 1,1,3,3-tetramethylbutylamine

Y0000204

Pravastatin 1,1,3,3-tetramethylbutylamine for assay CRS

Y0002294

 

Information on change of sales units

None.

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

Due to a stability issue, storage and shipping conditions will soon be modified for the following reference standard:

  • Bambuterol impurity mixture (Y0002206) CRS batch 1 will be stored at –20°C (previously +5°C) and shipped under Ice –20°C (previously ambient).

Content of the European Pharmacopoeia RS catalogue

The EDQM proposes more than 3 000 Ph. Eur. RSs 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:

  • the batch validity statement (BVS) 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 users ordering through the RS WebStore.

twitter facebook googleplus pinterest linkedin email