- 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:
- 13 replacement batches for European Pharmacopoeia (Ph. Eur.) reference standards:
|
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
|---|---|---|---|---|
|
Nystatin CRS |
8 |
100 mg |
79 EUR |
|
|
Hydroxocobalamin CRS |
2 |
15 mg |
79 EUR |
|
|
Amiodarone impurity D CRS |
4 |
20 mg |
79 EUR |
|
|
Fenbendazole impurity A CRS |
2 |
20 mg |
79 EUR |
|
|
Heptaminol impurity A CRS |
3 |
25 mg |
79 EUR |
|
|
Rabeprazole for system suitability CRS |
2 |
15 mg |
79 EUR |
|
|
Rivaroxaban CRS |
2 |
100 mg |
79 EUR |
|
|
Pidolate impurity B CRS |
6 |
110 mg |
79 EUR |
|
|
Sisomicin sulfate CRS |
4 |
60 mg |
79 EUR |
|
|
Hydrocortisone CRS |
9 |
70 mg |
79 EUR |
|
|
Hymecromone impurity B CRS |
3 |
25 mg |
79 EUR |
|
|
Fenbendazole CRS |
4 |
150 mg |
79 EUR |
|
|
Cholecalciferol CRS |
11 |
260 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Following the implementation of Supplement 10.5, the following standards are officially withdrawn from 1 July 2021.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. |
|
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 batch validity statement (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
Based on new stability information, storage and shipping conditions will be simplified on 15 December 2021 for the following reference standard:
- Calcipotriol monohydrate (Y0001042) CRS Batch 3 will be stored at +5 °C (instead of –20 °C) and shipped at ambient temperature (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 [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.