The EDQM announces the availability of:
- 2 New Ph. Eur. reference standards:
|
Catalogue code |
Name |
Unit Quantity |
|---|---|---|
|
Tilidine hydrochloride hemihydrate - * narc |
20 mg |
|
|
Tilidine for system suitability - * narc |
10 mg |
- 18 Replacement batches for Ph. Eur. reference standards:
|
Catalogue code |
Name |
Batch |
Unit Quantity |
|---|---|---|---|
|
Pheniramine impurity A |
2 |
20 mg |
|
|
Vinpocetine impurity C |
3 |
15 mg |
|
|
Spironolactone |
5 |
160 mg |
|
|
Calcium folinate |
8 |
110 mg |
|
|
Meloxicam impurity B |
3 |
5 mg |
|
|
Fosinopril impurity I |
2 |
5 mg |
|
|
Tramadol impurity A |
6 |
20 mg |
|
|
Sodium cetostearyl sulfate |
2 |
100 mg |
|
|
Isopropyl tetradecanoate |
5 |
2 mL |
|
|
Fluoxetine impurity C |
5 |
5 mg |
|
|
Aceclofenac impurity F |
4 |
15 mg |
|
|
Rifamycin sodium |
5 |
150 mg |
|
|
Oxybutynin impurity A |
5 |
20 mg |
|
|
Low-substituted hydroxypropylcellulose |
2 |
50 mg |
|
|
Pancuronium bromide for system suitability |
2 |
15 mg |
|
|
Racecadotril for peak identification |
2 |
5 mg |
|
|
Nitrendipine impurity A |
4 |
30 mg |
|
|
Cisplatin |
7 |
100 mg |
Information on reference standards removed from catalogue:
None.
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:
- Cimetidine FSS CRS batch 2 is stored at -20°C and shipped at +5 °C (batch 1 was stored at +5 °C and shipped ambiant).
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).