- New releases:
- Removal
- Future removal
- Change of sales units
- Change of price
- Change of EDQM storage/shipping conditions
- Removal of unit quantity in RS leaflets
- Change in the policy for withdrawing reference standards from sale
- Current non-availability
See also:
Content of the Ph. Eur. RS catalogue
The EDQM announces the availability of:
|
Catalogue code |
Name |
Batch |
Unit quantity |
|
Entecavir impurity F CRS |
3 |
10 mg |
|
|
4-Aminobenzoic acid CRS |
3 |
60 mg |
|
|
N-Acetyltryptophan CRS |
3 |
125 mg |
|
|
Gammacyclodextrin CRS |
4 |
120 mg |
|
|
Amlodipine impurity G CRS |
4 |
10 mg |
|
|
Levothyroxine sodium CRS |
5 |
100 mg |
|
|
Bifonazole for system suitability CRS |
2 |
10 mg |
|
|
Silicone elastomer CRS |
4 |
2000 |
|
|
Piroxicam for system suitability CRS |
6 |
15 mg |
|
|
Aciclovir for peak identification 1 CRS |
6 |
0.3 mg |
|
|
Verapamil hydrochloride CRS |
2 |
50 mg |
|
|
Fluconazole impurity B CRS |
6 |
15 mg |
|
|
Tristearin CRS |
2 |
180 mg |
|
|
Dextran 4 for calibration CRS |
2 |
50 mg |
|
|
Letrozole CRS |
3 |
80 mg |
|
|
Sulindac CRS |
4 |
100 mg |
|
|
Enterokinase BRP |
2 |
200 mg |
|
|
Catalpol CRS |
2 |
15 mg |
Information on reference standards removed from catalogue
None
Information on reference standards with a future removal from catalogue
- 01/04/2020
|
Catalogue code |
Name |
Comments |
|
Fluocortolone pivalate CRS |
|
|
|
Nomegestrol acetate CRS |
|
|
|
Prednisolone hexanoate CRS |
|
|
|
Testosterone for impurity D identification CRS |
|
|
|
Testosterone for system suitability CRS |
Replaced by Y0002174 Testosterone for system suitability A CRS |
|
|
Clobetasol for peak identification CRS |
|
|
|
Zolpidem impurity A CRS |
|
- 02/07/2021
|
Catalogue code |
Name |
Comments |
|
C2332000 |
Clomifene citrate for performance test CRS |
Removed from Ph. Eur. supplement 10.2 (in application from 01/07/2020) but kept on sales for an additional 6 months according to new policy (see “Change in the policy for withdrawing reference standards from sale”). |
|
Y0001850 |
Oxytetracycline for system suitability CRS |
Information on change of sales units
None
Information on change of price
Please note that the price for Everolimus CRS, Everolimus for system suitability CRS and Everolimus for impurity C identification CRS Batch 2 has changed to €300.
Information on change of EDQM storage/shipping conditions
None.
Removal of Unit quantity in RS leaflets
For information, the Unit quantity is removed from the leaflet of the Reference Standard for each batch released after February 2020 as this information is available on the label of the RS container.
Change in the policy for withdrawing reference standards from sale
A new policy will be applied from the application of Supplement 10.2 (01/07/2020). Detailed information is available in the news item of 24 January 2020.
Information on the current non-availability of a reference standard
Ph. Eur. Somatropin/Desamidosomatropin resolution mixture CRS (Y0000711) is currently unavailable.
In order to overcome the temporary shortage of this CRS and until the replacement batch is made available, it is advised to prepare the system suitability resolution solution for the test of related proteins described in the monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin) and 0952 (Somatropin for injection) by using the Ph. Eur. Somatropin CRS Batch 3 (Cat. No. S0947000).
See more information in the Note to users.
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 published 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 and is attached to your e-mail).
The EDQM will soon be launching a new and improved WebStore for Reference Standards, following up on its most recent user satisfaction survey.