- New releases
- Replacement batches for Ph. Eur. reference standards
- Removal
- Future removal
- Change of sales units
- Change of price
- Change of EDQM storage/shipping conditions
See also:
The EDQM announces the availability of:
-
10 new European Pharmacopoeia (Ph. Eur.) reference standards:
Catalogue code |
Name |
Unit quantity |
Price |
---|---|---|---|
Riociguat CRS |
1 |
130 mg |
|
Allopurinol impurity C CRS |
1 |
15 mg |
|
Fluticasone propionate for system suitability CRS |
1 |
15 mg |
|
Riociguat for FP system suitability CRS |
1 |
15 mg |
|
Riociguat for system suitability CRS |
1 |
15 mg |
|
Regorafenib impurity FP-C CRS |
1 |
20 mg |
|
Regorafenib impurity FP-B CRS |
1 |
15 mg |
|
Regorafenib for FP system suitability CRS |
1 |
10 mg |
|
Piperacillin impurity N CRS |
1 |
15 mg |
|
Pentobarbital sodium CRS - * psy |
1 |
40 mg |
-
22 replacement batches for Ph. Eur. reference standards:
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
---|---|---|---|---|
Cefpodoxime proxetil CRS |
2 |
80 mg |
79 EUR |
|
Methyl methacrylate CRS |
2 |
50 mg |
79 EUR |
|
Erythromycin for system suitability CRS |
2 |
15 mg |
79 EUR |
|
Fenofibrate CRS |
4 |
100 mg |
79 EUR |
|
Potassium clavulanate impurity G CRS |
4 |
5 mg |
79 EUR |
|
Dienogest CRS |
2 |
80 mg |
79 EUR |
|
Montelukast dicyclohexylamine CRS |
3 |
150 mg |
79 EUR |
|
Rabeprazole sodium hydrate CRS |
2 |
150 mg |
79 EUR |
|
Ibuprofen for peak identification CRS |
9 |
0.09 mg |
79 EUR |
|
Chlorpromazine impurity A CRS |
3 |
15 mg |
79 EUR |
|
Oxytetracycline hydrochloride CRS |
6 |
20 mg |
79 EUR |
|
Gabapentin CRS |
3 |
400 mg |
79 EUR |
|
Metoprolol impurity A CRS |
5 |
15 mg |
79 EUR |
|
Neohesperidin-dihydrochalcone CRS |
3 |
125 mg |
79 EUR |
|
Colistimethate sodium CRS |
3 |
26.2 mg |
79 EUR |
|
Glycerol monocaprylocaprate CRS |
3 |
500 |
79 EUR |
|
Propylene glycol monolaurate CRS |
2 |
100 mg |
79 EUR |
|
2,4-Dichlorobenzyl alcohol CRS |
2 |
250 mg |
79 EUR |
|
Cholesterol CRS |
5 |
80 mg |
79 EUR |
|
Valaciclovir for system suitability CRS |
2 |
10 mg |
79 EUR |
|
Tadalafil CRS |
3 |
200 mg |
79 EUR |
|
Amphotericin B for peak identification CRS |
4 |
10 mg |
79 EUR |
Information on reference standards removed from catalogue
None.
Information on reference standards with a future removal from catalogue
Following the implementation of Supplement 10.3, the following standards are officially withdrawn as of 1 January 2021.
Catalogue code |
Name |
Comments |
---|---|---|
Y0000055 |
Acamprosate calcium - reference spectrum |
Removed from Ph. Eur. supplement 10.3 (in application from 1 January 2021) but kept on sales for an additional 6 months according to EDQM policy (see news bulletin “Change in the policy for withdrawing reference standards from sale”). |
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 |
|
P2800000 |
Prednisolone acetate |
|
Y0000369 |
Primidone for peak identification |
|
Y0000239 |
Celiprolol for peak identification |
|
Y0000312 |
Celiprolol impurity I |
|
B1000000 |
Betamethasone |
|
Y0000883 |
Adrenaline with impurity F |
|
Y0001128 |
Epinastine for system suitability |
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).
Information on change of sales units
None.
Information on change of price
Please note the price change for Batch 2 of Everolimus CRS products, i.e. Everolimus for system suitability 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 October 2020 for the following reference standard:
- Calcipotriol FSS (Y0002041) CRS batch 1 will be stored at +5°C (previously -20°C) and shipped at ambient temperature (previously Ice -20°C).
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 PDF).
For your convenience, the Ph. Eur. RS catalogue is updated on a daily basis and can be downloaded in PDF format and 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 (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).