- New Ph. Eur. reference standards
- Replacement batches for Ph. Eur. reference standards
- Removal
- Future removal
- Change of sales units
- Information on change of price
- Change of EDQM storage/shipping conditions
See also:
The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the availability of:
- 3 new European Pharmacopoeia (Ph. Eur.) reference standards:
|
Catalogue code |
Name |
Unit quantity |
Price |
|
Dydrogesterone for impurity A identification |
0.002 mg |
79 EUR |
|
|
Flucloxacillin for peak identification CRS |
15 mg |
79 EUR |
|
|
Domperidone impurity mixture |
0.04 mg |
79 EUR |
- 11 replacement batches for Ph. Eur. reference standards:
|
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
|
Acemetacin impurity A CRS |
2 |
20 mg |
79 EUR |
|
|
Telmisartan for system suitability CRS |
6 |
0.26 mg |
79 EUR |
|
|
Thiopental for system suitability CRS |
5 |
10 mg |
79 EUR |
|
|
Oxytocin CRS |
7 |
41 mg |
90 EUR |
|
|
Cyproterone acetate for peak identification CRS |
2 |
15 mg |
79 EUR |
|
|
Oxcarbazepine impurity mixture CRS |
2 |
0.008 mg |
79 EUR |
|
|
Thebaine CRS - * narc |
2 |
15 mg |
79 EUR |
|
|
Atorvastatin impurity mixture CRS |
2 |
0.03 mg |
79 EUR |
|
|
Salicylic acid impurity B CRS |
4 |
15 mg |
79 EUR |
|
|
Doxycycline for system suitability CRS |
4 |
10 mg |
79 EUR |
|
|
Irinotecan hydrochloride trihydrate CRS |
2 |
170 mg |
79 EUR |
Information on reference standards removed from catalogue
- Supplement 10.6
Following the implementation of Supplement 10.6, the following standards are officially withdrawn from 1 January 2022.
|
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 batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details. |
|
Y0000623 |
Terazosin impurity L |
|
|
Y0000694 |
Bisacodyl for system suitability |
|
|
D2750100 |
Dipotassium clorazepate - reference spectrum |
|
|
Y0000666 |
Terazosin for system suitability |
|
|
Y0000622 |
Terazosin impurity A |
|
|
Y0001377 |
Nitrofural for peak identification |
|
|
Y0000204 |
Pravastatin 1,1,3,3-tetramethylbutylamine |
Information on reference standards with a future removal from catalogue
- Supplement 10.7
Following the implementation of Supplement 10.7, the following standards will be officially withdrawn from 1 April 2022.
|
Y0001327 |
Atorvastatin calcium trihydrate |
These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 October 2022. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 April 2023) to allow users to print the BVS. See “Change in the policy for withdrawing reference standards from sale” for more details. |
|
Y0001332 |
Atorvastatin impurity E |
|
|
Y0000340 |
Formoterol fumarate for system suitability |
|
|
Y0000820 |
Marbofloxacin for peak identification |
|
|
Y0002229 |
Atorvastatin for system suitability |
|
|
Y0001478 |
Thiopental for system suitability |
|
|
Y0002137 |
Alfacalcidol for impurity B identification |
|
|
S0400000 |
Senna extract CRS |
|
|
D2630000 |
Diphenoxylate hydrochloride - reference spectrum |
|
|
Y0001942 |
Gonadorelin for system suitability |
- Supplement 10.8
Following the implementation of Supplement 10.8, the following standards will be 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 BVS. See “Change in the policy for withdrawing reference standards from sale” for more details. |
|
Y0001005 |
Dydrogesterone impurity A |
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
Based on new stability information, shipping conditions were changed on 17 December 2021 for the following reference standard:
- Regorafenib FP-B (Y0002227) CRS batch 1 is shipped on Ice +5°C (previously ambient temperature).
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 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 [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.