- 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 |
|---|---|---|---|
|
Ciclosporin for system suitability A |
1 mg |
79 EUR |
|
|
Ethanolamine CRS |
30 mg |
79 EUR |
|
|
Oxybutynin hydrochloride for system suitability CRS |
15 mg |
79 EUR |
|
|
Dipotassium clorazepate monohydrate - reference spectrum |
1 |
79 EUR |
|
|
Beta-sitosterol for peak identification |
10 mg |
79 EUR |
|
|
Terazosin for system suitability A |
0.59 mg |
79 EUR |
|
|
Zidovudine for system suitability A CRS |
10 mg |
79 EUR |
|
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
|---|---|---|---|---|
|
Cabergoline CRS |
3 |
170 mg |
79 EUR |
|
|
Finasteride CRS |
4 |
130 mg |
79 EUR |
|
|
Ibuprofen impurity B CRS |
10 |
1.15 mL |
79 EUR |
|
|
Mesalazine for system suitability CRS |
6 |
10 mg |
79 EUR |
|
|
Bicalutamide CRS |
2 |
160 mg |
79 EUR |
|
|
Ibuprofen CRS |
6 |
150 mg |
79 EUR |
|
|
Captopril impurity D CRS |
3 |
15 mg |
79 EUR |
|
|
Chlortetracycline hydrochloride CRS |
6 |
100 mg |
79 EUR |
|
|
Clotrimazole CRS |
5 |
100 mg |
79 EUR |
|
|
Coumarin CRS |
2 |
160 mg |
79 EUR |
|
|
Dextran 250 for calibration CRS |
2 |
50 mg |
79 EUR |
|
|
Everolimus for system suitability CRS |
2 |
10 mg |
300 EUR |
|
|
Piperacillin CRS |
6 |
100 mg |
79 EUR |
|
|
Sulfobutylbetadex impurity D CRS |
2 |
40 mg |
79 EUR |
|
|
Betamethasone acetate CRS |
4 |
100 mg |
79 EUR |
|
|
Atropine impurity B CRS |
3 |
10 mg |
79 EUR |
|
|
Oseltamivir impurity B CRS |
3 |
10 mg |
79 EUR |
|
|
Captopril impurity B CRS |
3 |
15 mg |
79 EUR |
|
|
Diclofenac for system suitability CRS |
4 |
1 mg |
79 EUR |
|
|
Glibenclamide CRS |
4 |
50 mg |
79 EUR |
|
|
Quetiapine for system suitability CRS |
4 |
2 mg |
79 EUR |
|
|
Biperiden impurity A CRS |
3 |
20 mg |
79 EUR |
|
|
Triamcinolone acetonide for system suitability CRS |
3 |
10 mg |
79 EUR |
|
|
Acetylcysteine impurity C CRS |
12 |
10 mg |
79 EUR |
|
|
Dexamethasone CRS |
6 |
70 mg |
79 EUR |
|
|
Dextran 10 for calibration CRS |
2 |
50 mg |
79 EUR |
|
|
Fludarabine for system suitability CRS |
2 |
20 mg |
79 EUR |
|
|
Fluphenazine impurity mixture CRS |
2 |
0.07 mg |
79 EUR |
|
|
Gliclazide impurity B CRS |
5 |
50 mg |
79 EUR |
|
|
Paracetamol impurity J CRS |
2 |
15 mg |
79 EUR |
Information on reference standards removed from catalogue
- Supplement 10.3
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 |
Information on reference standards with a future removal from catalogue
- Supplement 10.4
Following the implementation of Supplement 10.4 (1 April 2021), the following standards will be removed from the catalogue:
|
Erythromycin for impurity M identification |
Y0001846 |
|
Amobarbital - * psy |
A0650000 |
|
Amobarbital sodium - * psy |
A0700000 |
|
Desmethylmetrifonate |
D0630000 |
|
Metrifonate |
M1845000 |
The following standards will also be removed and replaced:
|
Items removed |
Catalogue code |
Replaced by |
Catalogue code |
|---|---|---|---|
|
Atorvastatin impurity A |
Y0001328 |
Atorvastatin for system suitability |
Y0002229 |
|
Atorvastatin impurity B |
Y0001329 |
Atorvastatin for system suitability |
Y0002229 |
|
Atorvastatin impurity C |
Y0001330 |
Atorvastatin for system suitability |
Y0002229 |
|
Atorvastatin impurity D |
Y0001331 |
Atorvastatin for system suitability |
Y0002229 |
|
Aciclovir for system suitability |
Y0001264 |
Aciclovir for system suitability A |
Y0002245 |
|
Fluticasone propionate for impurity G identification |
Y0001755 |
Fluticasone propionate for system suitability |
Y0002249 |
|
Aciclovir for peak identification 1 |
Y0001271 |
Aciclovir for impurity C identification |
Y0002242 |
|
Procaine benzylpenicillin for peak identification |
Y0002077 |
Procaine benzylpenicillin impurity F |
Y0002171 |
|
Aciclovir for peak identification 2 |
Y0001269 |
Aciclovir for impurity G identification |
Y0002244 |
NB 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.
- 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 |
Y0002266 |
|
Ciclosporin for system suitability |
Y0000361 |
Ciclosporin for system suitability A |
Catalogue code not yet known |
NB 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
None.
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.
NEW: A button giving direct access to the web store has been added in the detailed view of each reference standard (below the BVS print button).
If you wish to place an order, you can send your request to the EDQM either:
- via the web store (this form can also be used to confirm a proforma invoice or a quotation you have already received from the EDQM);
- 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).