The EDQM announces the availability of:
- 11 new Ph. Eur. reference standards:
|
Catalogue code |
Name |
Unit Quantity |
|---|---|---|
|
Topiramate |
70 mg |
|
|
Topiramate impurity A |
20 mg |
|
|
Topiramate impurity E |
40 mg |
|
|
Benserazide for peak identification A |
10 mg |
|
|
Fenoterol for system suitability |
0.13 mg |
|
|
Mesterolone for system suitability |
15 mg |
|
|
Vincamine |
10 mg |
|
|
Dronedarone hydrochloride |
120 mg |
|
|
Oxytetracycline for system suitability A |
20 mg |
|
|
Chlortalidone for system suitability |
1.02 mg |
|
|
Benzydamine for system suitability |
10 mg |
- 28 replacement batches for Ph. Eur. reference standards:
|
Catalogue code |
Name |
Batch |
Unit Quantity |
|---|---|---|---|
|
Terconazole |
3 |
180 mg |
|
|
Malathion impurity B |
4 |
15 mg |
|
|
Gramicidin |
2 |
250 mg |
|
|
Glipizide impurity A |
2 |
15 mg |
|
|
Dinoprostone |
4 |
60 mg |
|
|
Parnaparin sodium |
4 |
200 mg |
|
|
Sildenafil impurity A |
2 |
5 mg |
|
|
Benzalkonium chloride for system suitability |
5 |
20 mg |
|
|
Glipizide impurity D |
2 |
10 mg |
|
|
Fluconazole for peak identification |
2 |
10 mg |
|
|
Sodium stearyl fumarate |
2 |
50 mg |
|
|
Ethylnicotinamide |
2 |
100 mg |
|
|
Dichlorodiaminocyclohexaneplatinum |
6 |
15 mg |
|
|
Flunarizine dihydrochloride |
4 |
50 mg |
|
|
Insulin glargine for peak identification |
2 |
3.2 mg |
|
|
Daunorubicinone |
4 |
15 mg |
|
|
Carvedilol impurity C |
3 |
15 mg |
|
|
Pefloxacin impurity B |
2 |
10 mg |
|
|
Azithromycin |
5 |
410 mg |
|
|
Metamizole impurity A |
5 |
15 mg |
|
|
Chloramphenicol disodium disuccinate |
4 |
45 mg |
|
|
Nicotinic acid impurity mixture |
2 |
0.12 mg |
|
|
Fluoxetine hydrochloride |
6 |
250 mg |
|
|
Ganciclovir |
2 |
120 mg |
|
|
Plastic additive 17 |
3 |
250 mg |
|
|
Ofloxacin impurity E |
5 |
20 mg |
|
|
Clonazepam impurity B |
3 |
5 mg |
|
|
Gefitinib |
2 |
100 mg |
Information on reference standards removed from catalogue:
Since 1 July 2019, the following Ph. Eur. standards have been removed from the catalogue:
|
Catalogue code |
Name |
|---|---|
|
Xylazine impurity mixture |
|
|
Moxifloxacin for peak identification |
|
|
Loperamide hydrochloride for system suitability |
|
|
Xylazine impurity C |
|
|
Flupentixol impurity F |
|
|
Flupentixol impurity D |
|
|
Dihydroergotamine tartrate |
Information on change of sales units:
SInce 1 July 2019, the number of vials per sales unit has been increased from 2 to 3 for the following Ph. Eur. standards:
|
Catalogue code |
Name |
|---|---|
|
Alfacalcidol |
Information on changes of storage / shipping conditions:
In order to ensure better stability, storage and shipping conditions have been changed for the following reference standards:
- Lacosamide FSS CRS batch 1: stored at -20°C and shipped at +5°C, as of 11 July 2019.
- Neamine CRS batch 6: stored at -20°C and shipped at -20°C, as of 11 July 2019.
- Podophyllotoxin CRS (Y0002002) and Podophyllotoxin FSS CRS (Y0002034): stored at +5°C and shipped at room temperature, as of 19 August 2019.
Note: all orders confirmed before the change date will be shipped with conditions valid at the time. This has no impact on the quality of the standard.
Information on reference standards currently out of stock:
Ph. Eur. Somatropin/Desamidosomatropin resolution mixture CRS (Y0000711) is currently unavailable. During this temporary shortage and until the replacement batch becomes made available, users of this CRS are advised to use the Ph. Eur. Somatropin CRS Batch 3 (Cat. No. S0947000) to prepare the system suitability solution for the tests described in monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin) and 0952 (Somatropin for injection).
See more information in the Note to users.
The Ph. Eur. Reference Standards 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:
- through 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 letterhead paper stating both the catalogue code and substance name, and attached to your email).