The EDQM announces the availability of:
- 15 New Ph. Eur. reference standards:
|
Catalogue code |
Name |
Unit Quantity |
|
Zolpidem for system suitability CRS |
10 mg |
|
|
Almotriptan for system suitability CRS |
10 mg |
|
|
Almotriptan malate CRS |
70 mg |
|
|
Testosterone impurity I CRS |
20 mg |
|
|
Mercaptopurine impurity B |
15 mg |
|
|
Rosuvastatin for peak identification CRS |
15 mg |
|
|
Mercaptopurine impurity D CRS |
15 mg |
|
|
Tranexamic acid impurity F CRS |
10 mg |
|
|
Tranexamic acid impurity C CRS |
10 mg |
|
|
Tranexamic acid impurity B CRS |
15 mg |
|
|
Exemestane for peak identification CRS |
10 mg |
|
|
Pyrantel impurity C CRS |
30 mg |
|
|
Testosterone for ID and assay CRS |
90 mg |
|
|
Donepezil hydrochloride monohydrate CRS |
20 mg |
|
|
Sulfamethizole for system suitability CRS |
10 mg |
- 16 Replacement batches for Ph. Eur. reference standards:
|
Catalogue code |
Name |
Batch |
Unit |
|
Benzylpenicillin potassium CRS |
3 |
100 mg |
|
|
Carbidopa CRS |
3 |
50 mg |
|
|
Deslanoside CRS |
3 |
160 mg |
|
|
Prazepam CRS |
2 |
15 mg |
|
|
Amphotericin B CRS |
6 |
100 mg |
|
|
Mesterolone CRS |
3 |
120 mg |
|
|
Etodolac for peak identification CRS |
3 |
0.41 mg |
|
|
Lamotrigine impurity E CRS |
2 |
15 mg |
|
|
Meloxicam impurity C CRS |
4 |
10 mg |
|
|
Amikacin for system suitability CRS |
4 |
15 mg |
|
|
Epinastine for system suitability CRS |
2 |
10 mg |
|
|
Cimetidine for system suitability CRS |
2 |
0.51 mg |
|
|
Tiotropium impurity mixture CRS |
3 |
0.08 mg |
|
|
Montelukast racemate CRS |
4 |
0.1 mg |
|
|
Imatinib impurity A CRS |
2 |
0.03 mg |
|
|
Selamectin for peak identification CRS |
3 |
5 mg |
Information on reference standards removed from catalogue:
None.
Information on reference standards with a future removal from catalogue:
- 01/01/2020
|
Catalogue code |
Name |
Comments |
|
Copovidone - reference spectrum |
|
|
|
Carmustine - reference spectrum |
Replaced by Y0002128 Carmustine CRS |
|
|
Norpseudoephedrine hydrochloride CRS - * psy |
Unfortunately, due to the delays to get the export permits (10 weeks), we are no longer able to send this item before 01/01/20. Orders from outside France are, therefore, unfortunately, no longer accepted. The deliveries to France are still possible. |
|
|
Propyl gallate CRS |
Replaced by Y0002116 Propyl gallate for ID and assay CRS |
|
|
Fenoterol for peak identification CRS |
|
|
|
Chlortalidone for peak identification CRS |
Replaced by Y0002129 Chlortalidone for system suitability CRS |
|
|
Benserazide for peak identification CRS |
Replaced by Y0002115 Benserazide for peak identification A CRS |
|
|
Alfacalcidol for system suitability CRS |
|
- 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 |
|
Information on change of sales units:
|
From 01/07/2019, the number of vials per sales unit is increased from 2 to 3 for: |
Information on change of EDQM storage / shipping conditions:
In order to ensure better stability, storage and shipping conditions have been changed for the following reference standard:
- Thiopental for system suitability CRS batch 4 is stored at -20°C and shipped at -20 °C (batch 3 was stored at +5 °C and shipped ambient).
In order to ensure better stability, storage and shipping conditions will be changed for the following reference standard on 16/10/2019:
|
Catalogue code |
Name |
Storage conditions |
Shipping conditions |
|
Fingolimod hydrochloride CRS |
Current: -20°C Future: +5°C |
Current: Ice -20°C Future: Ambient |
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 2900 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 European Pharmacopoeia (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 here as well as in XML format here.
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 email to [email protected] (in this case, please ensure that your order is on your company letter headed paper stating both the catalogue code and substance name and attached to your email).