- New Ph. Eur. reference standards
- Replacement batches for Ph. Eur. reference standards
- Removal
- Future removal
- Change of sales units
- Technical information
- 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 release of:
|
Catalogue code |
Name |
Unit quantity |
Price |
|
Mirabegron impurity C CRS |
10 mg |
79 EUR |
|
|
Promazine impurity C CRS |
15 mg |
79 EUR |
|
|
Marbofloxacin impurity mixture A CRS |
0.008 mg |
79 EUR |
|
|
Valganciclovir containing impurity T CRS |
15 mg |
79 EUR |
|
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
|
Potassium sucrose octasulfate CRS |
3 |
100 mg |
79 EUR |
|
|
Meldonium impurity F CRS |
2 |
25 mg |
79 EUR |
|
|
Minoxidil for system suitability CRS |
3 |
10 mg |
79 EUR |
|
|
Rizatriptan benzoate CRS |
2 |
200 mg |
79 EUR |
|
|
Deferasirox for system suitability CRS |
2 |
10 |
79 EUR |
|
|
Etilefrine impurity A CRS |
2 |
25 mg |
79 EUR |
|
|
Phenylbutazone CRS |
2 |
100 mg |
79 EUR |
|
|
Azithromycin for system suitability CRS |
12 |
0.1 mg |
79 EUR |
|
|
Clazuril CRS |
2 |
10 mg |
79 EUR |
|
|
Dosulepin impurity A CRS |
3 |
30 mg |
79 EUR |
|
|
Flavoxate impurity B CRS |
2 |
10 mg |
79 EUR |
|
|
Tiapride hydrochloride CRS |
2 |
30 mg |
79 EUR |
|
|
Acesulfame potassium CRS |
3 |
50 mg |
79 EUR |
|
|
Digoxigenin CRS |
4 |
10 mg |
79 EUR |
|
|
Clobetasol propionate for peak identification CRS |
2 |
2 mg |
79 EUR |
|
|
Nimesulide impurity D CRS |
7 |
0.004 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Following the implementation of Supplement 10.8, the following standards are officially withdrawn from 1 July 2022.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Following the implementation of the 11th edition, the following standards will be officially withdrawn (replaced) from 1 January 2023.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 |
Information on change of sales units
- T0800000 (Theophylline CRS): 2 vials are now provided.
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.
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 changed on 17 October 2022 for the following reference standard:
- Valerian dry extract (Y0000583) HRS batch 4 will be stored at +5 °C (previously –20°C) and shipped on Ice +5°C (previously Ice –20°C).
- Piperacillin (P1890000) CRS batch 6 will be stored at –20 °C (previously +5 °C) and shipped on Ice –20 °C (previously Ambient).
- Piperacillin for peak identification (Y0002235) CRS batch 1 will be stored at –20 °C (previously +5 °C) and shipped on Ice –20 °C (previously Ambient).
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.
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.