- New Ph. Eur reference standards
- Replacement batches for Ph. Eur. reference standards
- Removal
- Future removal
- Change of sales units
- Change of price
- Change of EDQM storage/shipping conditions
- Removal of unit quantity in RS leaflets
- Change in the policy for withdrawing reference standards from sale
- Current non-availability
See also:
Content of the Ph. Eur. RS catalogue
The EDQM announces the availability of:
|
Catalogue code |
Name |
Unit Quantity |
|
Betiatide impurity D |
10 mg |
|
|
Betiatide |
20 mg |
|
|
Deferasirox CRS |
70 mg |
|
|
Celiprolol for system suitability CRS |
20 mg |
|
|
Fluoxetine impurity A CRS |
15 mg |
|
|
Ofloxacin impurity D CRS |
20 mg |
|
|
Deferasirox impurity B CRS |
10 mg |
|
|
Rivaroxaban for system suitability CRS |
5 mg |
|
|
Rivaroxaban impurity A CRS |
5 mg |
|
Catalogue code |
Name |
Batch |
Unit |
|
Chondroitin sulfate sodium CRS |
3 |
350 mg |
|
|
Fexofenadine impurity C CRS |
2 |
5 mg |
|
|
Naproxen impurity L CRS |
3 |
15 mg |
|
|
Trimyristin CRS |
3 |
1000 mg |
|
|
Hydroxyethyl salicylate CRS |
3 |
125 mg |
|
|
Candesartan cilexetil CRS |
2 |
60 mg |
|
|
Promethazine for peak identification CRS |
3 |
5 mg |
|
|
Paclitaxel semi-synthetic for system suitability CRS |
3 |
1.01 mg |
|
|
Acesulfame potassium impurity B CRS |
5 |
15 mg |
|
|
Pemetrexed impurity mixture CRS |
3 |
0.002 mg |
|
|
Praziquantel for system suitability CRS |
2 |
10 mg |
|
|
Lauric acid CRS |
2 |
1500 mg |
|
|
Nimesulide impurity D CRS |
6 |
0.004 mg |
|
|
Dehydrohexetidine CRS |
3 |
50 mg |
|
|
Flavoxate impurity A CRS |
2 |
15 mg |
|
|
Oxprenolol hydrochloride CRS |
2 |
50 mg |
|
|
Flurbiprofen impurity A CRS |
4 |
25 mg |
|
|
Dexamethasone pivalate CRS |
2 |
50 mg |
Please note that the price of Everolimus CRS, Everolimus for system suitability CRS and Everolimus for impurity C identification CRS batch 2 will be changed to €300.
Information on reference standards removed from the catalogue:
As of 1 April 2020, the following standards have been removed from the catalogue.
|
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 reference standards to be removed from the catalogue in future:
- 2 July 2021
|
Catalogue code |
Name |
Comments |
|
C2332000 |
Clomifene citrate for performance test CRS |
Removed from Ph. Eur. Supplement 10.2 (in effect from 1 July 2020) but kept on sale for an additional 6 months according to policy |
|
Y0001850 |
Oxytetracycline for system suitability CRS |
Information on change of sales units:
|
None. |
Information on changes to EDQM storage/shipping conditions:
In order to ensure better stability, storage and shipping conditions will be changed on 15 May 2020 for the following reference standards:
- Calcifediol for impurity D identification CRS batch 1 will be stored at +5 °C (previously -20 °C) and shipped at ambient temperature (previously Ice -20 °C).
- Calcifediol CRS batch 6 will be stored at +5 °C (previously -20 °C) and shipped at ambient temperature (previously Ice -20 °C)
Change in the policy for withdrawing reference standards from sale
At the present time, a reference standard is withdrawn from the catalogue either on the date that a revised monograph which no longer refers to it becomes applicable, or the date on which a monograph is officially withdrawn from the Ph. Eur.
A number of users have informed us that regulatory requirements in their country permit the use of these reference standards (and therefore the corresponding monographs) even after their official withdrawal date. To help these users, the EDQM has decided to modify its withdrawal policy.
Therefore, stocks permitting, sale of these reference standards will continue for 6 months after the official withdrawal date. Similarly, they will remain in the catalogue for a period of 12 months to allow users to print the Batch Validity Statement (BVS) and/or finalise the necessary procedures for controlled substances.
Example:
Fluocortolone pivalate CRS (F0230000) was used in monograph 1212.
The revised monograph entered into force on 1 April 2020.
Current situation:
Reference standard F0230000 would have been withdrawn from sale on 1 April 2020.
New policy:
Reference standard F0230000 will be available for purchase until 1 October 2020 (1 April 2020 + 6 months) and will feature in the catalogue until 1 April 2021 (1 April 2020 + 1 year).
Note: although it will still be listed in the catalogue until 1 April 2021, it will not be possible to order the reference standard after 1 October 2020.
The validity of this standard will thus end on 2 April 2021. As of this date, it will no longer be displayed in the catalogue and therefore can no longer be used.
This policy will be applied from the application of Supplement 10.2 (1 July 2020).
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 monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin) and 0952 (Somatropin for injection) by using 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 offers more than 3 000 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 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 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 is attached to your email).