- 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 |
|---|---|---|---|
|
Atorvastatin calcium CRS |
150 mg |
79 EUR |
|
|
Chelerythrine chloride CRS |
25 mg |
79 EUR |
|
|
Phenoxybenzamine for system suitability SCR |
10 mg |
79 EUR |
|
|
Phenoxybenzamine hydrochloride CRS |
80 mg |
79 EUR |
|
|
Phenoxybenzamine impurity B SCR |
10 mg |
79 EUR |
|
|
Palladium solution |
10.2 mL |
79 EUR |
|
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
|---|---|---|---|---|
|
Fluticasone propionate for impurity G identification CRS |
2 |
15 mg |
79 EUR |
|
|
Levocarnitine impurity A CRS |
5 |
30 mg |
79 EUR |
|
|
Granisetron impurity E CRS |
4 |
15 mg |
79 EUR |
|
|
Sodium hyaluronate BRP |
3 |
300 mg |
79 EUR |
|
|
Diclofenac sodium CRS |
5 |
80 mg |
79 EUR |
|
|
Rosuvastatin impurity G CRS |
4 |
0.004 mg |
79 EUR |
|
|
Diphenhydramine impurity A CRS |
5 |
20 mg |
79 EUR |
|
|
Glucosamine for system suitability CRS |
3 |
3 mg |
79 EUR |
|
|
Norethisterone CRS |
4 |
25 mg |
79 EUR |
|
|
Oxfendazole with impurity D CRS |
2 |
20 mg |
79 EUR |
|
|
Chlorpromazine hydrochloride CRS |
2 |
150 mg |
79 EUR |
|
|
Venlafaxine hydrochloride CRS |
3 |
50 mg |
79 EUR |
|
|
Aciclovir for impurity C identification CRS |
2 |
0.3 mg |
79 EUR |
|
|
Pethidine impurity A CRS |
3 |
20 mg |
79 EUR |
|
|
Dequalinium chloride |
2 |
50 mg |
79 EUR |
|
|
Trimethoprim for system suitability CRS |
5 |
0.00075 mg |
79 EUR |
Information on reference standards removed from catalogue
- Supplement 10.4
Following the implementation of Supplement 10.4, the following standards are officially withdrawn from 01 April 2021.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 01 July 2021.
|
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 01 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.
|
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 01 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 – sales unit is changed (06/07/2021) from one to two units.
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
Due to stability issue, shipping conditions have been modified on 01/07/2021 for the following reference standard:
- Prilocaine (P2939000) CRS batch 2 is shipped under Ice +5°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.
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 has been prepared to help user ordering through the RS webstore.