- 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 |
|
Diosmin for Sheperd's purse CRS |
40 mg |
79 EUR |
|
|
Melatonin for system suitability CRS |
0.5 mg |
79 EUR |
|
|
Levomepromazine for system suitability CRS |
15 mg |
79 EUR |
23 replacement batches for Ph. Eur. reference standards:
|
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
|
Tigecycline impurity B CRS |
2 |
15 mg |
79 EUR |
|
|
Tribenoside impurity A CRS |
5 |
70 mg |
79 EUR |
|
|
Betamethasone sodium phosphate CRS |
5 |
100 mg |
79 EUR |
|
|
Bicalutamide for system suitability CRS |
3 |
10 mg |
79 EUR |
|
|
Brompheniramine maleate CRS |
3 |
50 mg |
79 EUR |
|
|
Fluphenazine impurity mixture CRS |
3 |
n/a |
79 EUR |
|
|
Iodixanol impurity C CRS |
2 |
10 mg |
79 EUR |
|
|
Neomycin sulfate for microbiological assay CRS |
7 |
25 mg |
79 EUR |
|
|
Thioctic acid for system suitability CRS |
3 |
15 mg |
79 EUR |
|
|
Cholecalciferol impurity A CRS |
2 |
0.06 mg |
79 EUR |
|
|
Chloramphenicol for peak identification CRS |
2 |
15 mg |
79 EUR |
|
|
Coagulation Factors V, VIII, XI and XIII plasma BRP |
2 |
1 mg |
90 EUR |
|
|
Human immunoglobulin for anticomplementary activity BRP |
3 |
10 g |
79 EUR |
|
|
Somatropin CRS |
4 |
55 mg |
150 EUR |
|
|
Deslanoside CRS |
4 |
160 mg |
79 EUR |
|
|
Pravastatin 1,1,3,3-tetramethylbutylamine CRS |
3 |
30 mg |
79 EUR |
|
|
Thiocolchicoside hydrate CRS |
2 |
60 mg |
79 EUR |
|
|
Atomoxetine impurity B CRS |
2 |
10 mg |
79 EUR |
|
|
Calcium folinate CRS |
9 |
110 mg |
79 EUR |
|
|
Carbamazepine impurity A CRS |
7 |
20 mg |
79 EUR |
|
|
Insulin aspart CRS |
5 |
8 mg |
90 EUR |
|
|
Sulfanilamide CRS |
3 |
100 mg |
79 EUR |
|
|
Trypsin BRP |
3 |
100 mg |
79 EUR |
Information on reference standards removed from catalogue
- Supplement 10.7
Following the implementation of Supplement 10.7, the following standards are officially withdrawn from 1 April 2022.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 batch validity statement (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 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 (11.0), 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
- Not applicable.
Due to a quality issue, the distribution of Cholecalciferol for system suitability CRS 11 has been suspended. Users still having this 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, shipping conditions were modified on 15 July 2022 for the following reference standard:
- Fenoterol for system suitability (Y0002102) CRS batch 1 is shipped on Ice+5°C (previously at 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 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.