- 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 EDQM announces the availability of:
Catalogue code |
Name |
Unit quantity |
Price |
---|---|---|---|
Bisacodyl for system suitability A |
10 mg |
79 EUR |
|
Somatostatin Impurity B |
0.01 mg |
90 EUR |
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
---|---|---|---|---|
Ketoprofen CRS |
3 |
50 mg |
79 EUR |
|
Nifedipine impurity A CRS |
2 |
25 mg |
79 EUR |
|
Plastic additive 09 CRS |
4 |
250 mg |
79 EUR |
|
Methionine CRS |
3 |
60 mg |
79 EUR |
|
Nicergoline for peak identification CRS |
2 |
1 mg |
79 EUR |
|
Paclitaxel CRS |
4 |
40 mg |
79 EUR |
|
Acebutolol impurity C CRS |
2 |
20 mg |
79 EUR |
|
Clarithromycin CRS |
4 |
170 mg |
79 EUR |
|
Diltiazem for system suitability CRS |
3 |
10 mg |
79 EUR |
|
Flunixin impurity C CRS |
4 |
55 mg |
79 EUR |
|
Labetalol hydrochloride CRS |
3 |
110 mg |
79 EUR |
|
7-Aminodesacetoxycephalosporanic acid CRS |
3 |
30 mg |
79 EUR |
|
Dydrogesterone impurity A CRS |
3 |
6 mg |
79 EUR |
|
Eugenol CRS |
4 |
1 mL |
79 EUR |
|
Flucloxacillin sodium CRS |
9 |
250 mg |
79 EUR |
|
Oseltamivir impurity C CRS |
3 |
15 mg |
79 EUR |
|
Benzaldehyde CRS |
3 |
150 mg |
79 EUR |
|
Capecitabine CRS |
2 |
150 mg |
79 EUR |
|
Metronidazole impurity A CRS |
4 |
15 mg |
79 EUR |
|
Ouabain CRS |
3 |
150 mg |
79 EUR |
Information on reference standards removed from catalogue
Following the implementation of Supplement 10.3, the following standards are officially withdrawn from 1 January 2021.
Catalogue code |
Name |
Comments |
---|---|---|
Y0000055 |
Acamprosate calcium - reference spectrum |
These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of June 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 31 December 2021) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details. |
F0253000 |
Fluoxetine hydrochloride |
|
O0120010 |
Ofloxacin impurity A |
|
M0400000 |
Meprobamate CRS |
|
Y0000035 |
Carisoprodol CRS |
|
Y0000036 |
Carisoprodol impurity A CRS |
|
N0050000 |
Nalidixic acid CRS |
|
Y0001792 |
Nalidixic acid impurity C CRS |
|
Y0000369 |
Primidone for peak identification |
|
Y0000239 |
Celiprolol for peak identification |
|
Y0000312 |
Celiprolol impurity I |
|
Y0000883 |
Adrenaline with impurity F |
|
Y0001128 |
Epinastine for system suitability |
- Supplement 10.4
Following the implementation of Supplement 10.4, the following standards are officially withdrawn from 1 April 2021.
Catalogue code |
Name |
Comments |
---|---|---|
Y0001846 |
Erythromycin for impurity M identification |
These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of September 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 31 March 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. |
A0650000 |
Amobarbital - * psy |
|
A0700000 |
Amobarbital sodium - * psy |
|
D0630000 |
Desmethylmetrifonate |
|
M1845000 |
Metrifonate |
|
Y0001328 |
Atorvastatin impurity A |
|
Y0001329 |
Atorvastatin impurity B |
|
Y0001330 |
Atorvastatin impurity C |
|
Y0001331 |
Atorvastatin impurity D |
|
Y0001264 |
Aciclovir for system suitability |
|
Y0001755 |
Fluticasone propionate for impurity G identification |
|
Y0001271 |
Aciclovir for peak identification 1 |
|
Y0002077 |
Procaine benzylpenicillin for peak identification |
|
Y0001269 |
Aciclovir for peak identification 2 |
Information on reference standards with a future removal from catalogue
- Supplement 10.5
Following the implementation of Supplement 10.5 (1 July 2021), the following standards will be removed from the catalogue.
Diflunisal |
D1750000 |
Codeine impurity A (O-methylcodeine) |
Y0000334 |
Theobromine |
T0700000 |
The following standards will also be removed and replaced.
Items removed |
Catalogue code |
Replaced by |
Catalogue code |
---|---|---|---|
Zidovudine for system suitability |
Y0001641 |
Zidovudine for system suitability A |
|
Ciclosporin for system suitability |
Y0000361 |
Ciclosporin for system suitability A |
N.B. 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 30 June 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.
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 will be simplified on 15 June 2021 for the following reference standard:
Name |
Catalogue Code |
Batch |
Current shipping conditions |
New shipping conditions |
---|---|---|---|---|
Human coagulation factor IX concentrate BRP |
H0920500 |
3 |
Ice –20° C |
Ambient temp. |
Important information:
Please note that due to their stability profile these standards may be shipped at ambient temperature, but that they should be stored at –20°C upon receipt.
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 quantity allowed for each user is now directly displayed in the detailed view of the online catalogue.
How to place an RS order
If you wish to place an order, you can send your request to the EDQM either:
- via the web store;
- 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 entitled “How to place an order through the reference standards Webstore” has been prepared to help users ordering through the RS Webstore.
NEW: in case of sales restrictions, the quantities allowed now appear in the online catalogue and in the catalogue in XML format.