The EDQM announces:
- New Ph. Eur. reference standards
- Replacement batches for Ph. Eur. reference standards
- Removal
- Future removal
- Change of sales unit
- Change of EDQM storage/shipping conditions
- Current non-availability
Content of the Ph. Eur. RS catalogue
|
Catalogue code |
Name |
Unit quantity |
|
Mercaptopurine impurity A CRS |
15 mg |
|
|
Squalene |
500 mg |
|
|
Rosuvastatin impurity mixture CRS |
0.002 mg |
|
|
Fluocortolone pivalate for system suitability CRS |
10 mg |
|
|
Octreotide impurity mixture CRS |
0.01 mg |
|
|
Octreotide for NMR identification CRS |
2 mg |
|
|
Octreotide CRS |
11 mg |
|
Catalogue code |
Name |
Batch |
Unit quantity |
|
Ceftazidime for peak identification CRS |
3 |
13 mg |
|
|
Levodropropizine impurity C CRS |
2 |
420 mg |
|
|
Xylitol CRS |
3 |
220 mg |
|
|
Valerian dry extract HRS |
4 |
500 mg |
|
|
Rifamycin B CRS |
4 |
25 mg |
|
|
Interferon alfa-2b CRS |
7 |
200 µL |
|
|
Quinine sulfate CRS |
3 |
300 mg |
|
|
Articaine impurity E CRS |
3 |
10 mg |
|
|
Resveratrol CRS |
2 |
25 mg |
|
|
Lithium clavulanate CRS |
9 |
125 mg |
|
|
Captopril impurity B CRS |
2 |
10 mg |
|
|
Moxidectin for system suitability CRS |
3 |
10 mg |
|
|
Cyanocobalamin CRS |
6 |
20 mg |
|
|
Gemcitabine impurity C CRS |
2 |
5 mg |
|
|
Dexamethasone sodium phosphate for peak identification CRS |
2 |
10 mg |
|
|
Neomycin sulfate for microbiological assay CRS |
6 |
25 mg |
|
|
Dicloxacillin sodium CRS |
6 |
250 mg |
|
|
Permethrin for system suitability CRS |
3 |
60 mg |
|
|
Celecoxib impurity B CRS |
3 |
10 mg |
|
|
Phenazone impurity A CRS |
2 |
20 mg |
|
|
Vardenafil hydrochloride CRS |
2 |
130 mg |
|
|
Medroxyprogesterone acetate for peak identification CRS |
2 |
25 mg |
|
|
Cholecalciferol for system suitability CRS |
9 |
1 mL |
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, delays in obtaining export permits (10 weeks), prevent us from sending this item before 01/01/20. For this reason, orders from outside France are no longer accepted. Deliveries in 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:
None.
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 now stored at –20°C and shipped at
–20°C (batch 3 was stored at +5°C and shipped at ambient temperature). - Fingolimod hydrochloride CRS batch 1 is now stored at +5°C and shipped at ambient temperature (the same batch was previously stored at –20°C and shipped at –20°C).
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.
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 is on your company letterhead paper, that it states both the catalogue code and substance name and is attached to your e-mail).