- New releases:
- Removal
- Future removal
- Change of sales units
- Change of EDQM storage/shipping conditions
- Change in the policy for withdrawing reference standards from sale
See also:
Content of the Ph. Eur. RS catalogue
How to place an RS order
The EDQM announces the availability of:
|
Catalogue code |
Name |
Unit quantity |
|---|---|---|
|
Clomifene citrate for ID and assay |
50 mg |
|
|
Rhein CRS |
25 mg |
|
|
Senna Extract HRS |
25 mg |
|
|
Sennoside B CRS |
15 mg |
|
Catalogue code |
Name |
Batch |
Unit quantity |
|---|---|---|---|
|
Paclitaxel impurity C CRS |
3 |
10 mg |
|
|
Diacerein impurity mixture CRS |
2 |
0.014 mg |
|
|
Human tetanus immunoglobulin BRP |
2 |
50 mg |
|
|
Alfuzosin for system suitability A CRS |
2 |
10 mg |
|
|
Acetylsalicylic acid for peak identification CRS |
5 |
10.3 mg |
|
|
Ciprofloxacin hydrochloride CRS |
7 |
100 mg |
|
|
Closantel for system suitability CRS |
2 |
20 mg |
|
|
Pivmecillinam impurity C CRS |
3 |
20 mg |
|
|
Asiaticoside CRS |
2 |
40 mg |
|
|
Dermatan sulfate and over-sulfated chondroitin sulfate CRS |
4 |
1 mL |
|
|
Thiamazole CRS |
2 |
30 mg |
|
|
Delta-3-Cefaclor CRS |
5 |
15 mg |
|
|
Hydrocortisone acetate for peak identification CRS |
3 |
15 mg |
|
|
Ketoconazole CRS |
3 |
150 mg |
|
|
Saw palmetto extract HRS |
2 |
8000 mg |
|
|
Modafinil CRS |
2 |
130 mg |
|
|
Diosmin CRS |
7 |
70 mg |
|
|
Tamsulosin hydrochloride CRS |
2 |
10 mg |
|
|
Rutoside trihydrate CRS |
4 |
100 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 EDQM storage/shipping conditions
In order to ensure better stability, storage and shipping conditions will be changed on 16/03/2020 for the following reference standard:
- Beta-Ecdysterone CRS batch 1 will be stored at +5 °C and shipped at ambient temperature.
In order to ensure better stability, storage and shipping conditions have been changed for the following reference standard:
- Enalapril impurity mixture A CRS batch 2 is now stored at –20 °C and shipped at +5°C.
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 for Indian users: shipment of Oxytocin CRS to India
The Ministry of Health and Family Welfare of India has lifted the ban on Oxytocin reference standards imported exclusively for the purpose of test and analysis.
The EDQM is therefore now in a position to ship Oxytocin CRS and Oxytocin/Desmopressin validation mixture CRS (catalogue code O0700000 and O0770000) to India again.
Shipment to China
Due to the coronavirus situation, the EDQM is experiencing issues in shipping Reference Standards to China. As the situation is changing rapidly, the EDQM will contact all concerned users to agree on the best possible course of action (see EDQM portal news of 12 February 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).
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).