- 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 |
---|---|---|---|
Alfacalcidol impurity B |
15 mg |
300 EUR |
|
Formoterol for system suitability |
10 mg |
79 EUR |
|
Chenodeoxycholic acid for peak identification |
50 mg |
79 EUR |
|
Chenodeoxycholic acid for system suitability |
50 mg |
79 EUR |
|
Methylaminolevulinate impurity B |
30 mg |
79 EUR |
|
Fluticasone furoate for peak identification |
10 mg |
79 EUR |
|
Fluticasone furoate for system suitability CRS |
15 mg |
79 EUR |
|
Trazodone for system suitability CRS |
10 mg |
79 EUR |
|
Trazodone hydrochloride CRS |
70 mg |
79 EUR |
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
---|---|---|---|---|
Carbocisteine CRS |
3 |
40 mg |
79 EUR |
|
Dimethyl sulfoxide CRS |
4 |
1 mL |
79 EUR |
|
Sulfobutylbetadex impurity C CRS |
2 |
40 mg |
79 EUR |
|
Testosterone caproate CRS |
2 |
20 mg |
79 EUR |
|
Atropine impurity B CRS |
4 |
15 mg |
79 EUR |
|
Atorvastatin impurity D CRS |
6 |
5 mg |
79 EUR |
|
Meloxicam impurity A CRS |
3 |
15 mg |
79 EUR |
|
Cisplatin impurity B CRS |
3 |
15 mg |
79 EUR |
|
Human immunoglobulin for electrophoresis BRP |
4 |
50 mg |
79 EUR |
|
Fluoxetine impurity B CRS |
8 |
15 mg |
79 EUR |
|
Fluticasone impurity D CRS |
5 |
15 mg |
79 EUR |
|
Silicone oil CRS |
3 |
1 mL |
79 EUR |
|
Tryptophan CRS |
3 |
100 mg |
79 EUR |
|
Cefradine impurity mixture CRS |
2 |
0.04 |
79 EUR |
|
Hexetidine CRS |
3 |
100 mg |
79 EUR |
|
Kanamycin B sulfate CRS |
4 |
20 mg |
79 EUR |
|
Testosterone decanoate CRS |
4 |
60 mg |
79 EUR |
|
Dalteparin sodium CRS |
4 |
250 mg |
79 EUR |
|
Teicoplanin CRS |
3 |
50 mg |
79 EUR |
|
Tramadol hydrochloride CRS |
4 |
50 mg |
79 EUR |
|
Vinpocetine impurity D CRS |
3 |
15 mg |
79 EUR |
|
Xylometazoline hydrochloride CRS |
4 |
100 mg |
79 EUR |
Information on reference standards removed from catalogue
Following the implementation of Supplement 10.4, the following standards are officially withdrawn from 1 April 2021.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 |
- Supplement 10.5
Following the implementation of Supplement 10.5, the following standards are officially withdrawn from 1 July 2021.
Catalogue code |
Name |
Comments |
D1750000 |
Diflunisal |
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 1 July 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. |
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.
Catalogue code |
Name |
Comments |
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
Cholesterol CRS, C2155000 – As of 6 July 2021, the sales unit is changed from one unit to two.
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 July 2021 for the following reference standard:
- Beta-sitosterol (Y0001615) CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C).
Due to a stability issue, storage and shipping conditions have been modified, as of 17 June 2021, for the following reference standard:
- Benzylpenicillin for system suitability (Y0001889) CRS batch 1 is stored at –20°C (previously +5°C) and shipped under Ice –20°C (previously ambient).
Due to a stability issue, shipping conditions have been modified, as of 1 July 2021, for the following reference standard:
- Prilocaine (P2939000) CRS batch 2 is shipped under Ice +5°C (previously ambient).
NEW: Please be advised that as of July 2021, EDQM reference spectra will be sent exclusively by e-mail in PDF format and no longer in paper format by courier.
Therefore, within 48 hours of your order confirmation, you will receive a “Prior to dispatch” note and, in a separate e-mail, the PDF of your reference spectrum.
Please note that the PDF of the reference spectrum will be sent exclusively to the delivery contact stated on the order (in the “Delivered to” part of your Order confirmation). Only one delivery contact can be specified per order.
For any further information, please contact us via our HelpDesk.
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 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 “How to place an order through the reference standards WebStore” is available to help user ordering through the RS WebStore.