The EDQM announces the availability of:
- 15 New Ph. Eur. reference standards
|
Catalogue code |
Name |
Unit Quantity |
|---|---|---|
|
Carmustine |
60 mg |
|
|
Prasugrel hydrochloride |
70 mg |
|
|
Prasugrel for system suitability |
10 mg |
|
|
Propyl gallate for ID and assay |
80 mg |
|
|
Tapentadol impurity C |
10 mg |
|
|
Tapentadol impurity A |
10 mg |
|
|
Nicotinic acid for equipment qualification |
250 mg |
|
|
Alfacalcidol for impurity B identification |
5 mg |
|
|
Propranolol for system suitability |
15 mg |
|
|
Alfacalcidol for system suitability A |
5 mg |
|
|
Benzydamine Hydrochloride |
10 mg |
|
|
Tapentadol hydrochloride - * psy |
80 mg |
|
|
Tetracaine |
10 mg |
|
|
Dronedarone impurity B |
10 mg |
|
|
Procaine benzylpenicillin for peak identification |
15 mg |
- 22 Replacement batches for Ph. Eur. reference standards
|
Catalogue code |
Name |
Batch |
Unit Quantity |
|---|---|---|---|
|
Clobetasone butyrate for system suitability |
2 |
20 mg |
|
|
Valsartan for peak identification |
3 |
10 mg |
|
|
Prilocaine |
2 |
150 mg |
|
|
Acitretin |
3 |
100 mg |
|
|
Cefprozil impurity A |
2 |
20 mg |
|
|
Terbinafine for system suitability |
3 |
10 mg |
|
|
Nifedipine impurity B |
2 |
25 mg |
|
|
Clonidine hydrochloride |
2 |
25 mg |
|
|
Calcium oxalate monohydrate |
2 |
100 mg |
|
|
Desmopressin |
10 |
1 mg |
|
|
Insulin glargine |
5 |
15 mg |
|
|
Hydrochlorothiazide for peak identification |
4 |
10 mg |
|
|
Allantoin |
2 |
60 mg |
|
|
Tributyl acetylcitrate |
3 |
1 mL |
|
|
Cefepime dihydrochloride monohydrate for system suitability |
3 |
15 mg |
|
|
Cefazolin |
5 |
150 mg |
|
|
Cefadroxil |
4 |
150 mg |
|
|
Metformin impurity F |
3 |
2 mL |
|
|
Lactulose for peak identification |
2 |
1900 mg |
|
|
Atorvastatin impurity A |
4 |
5 mg |
|
|
Prekallikrein activator in albumin BRP |
7 |
200 mg |
|
|
Framycetin sulfate |
8 |
25 mg |
Information on reference standards removed from catalogue
From 01/07/2019, the following Ph. Eur. standards have been removed from the catalogue:
|
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
|
From 01/07/2019, the number of vials per sales unit is increased from 2 to 3 for:
|
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).