- New Ph. Eur. reference standards
- Replacement batches for Ph. Eur. reference standards
- Removal
- Future removal
- Change of sales units
- Information on change of price
- Change of EDQM storage/shipping conditions
See also:
The EDQM announces the availability of:
- 9 new European Pharmacopoeia (Ph. Eur.) reference standards:
Catalogue code |
Name |
Unit quantity |
Price |
Sulindac for system suitability |
15 mg |
79 EUR |
|
Clomifene for peak identification |
20 mg |
79 EUR |
|
Nickel solution |
10 mL |
79 EUR |
|
Monotropein CRS |
10 mg |
150 EUR |
|
Fludarabine for peak identification |
15 mg |
79 EUR |
|
Aciclovir for system suitability A CRS |
20 mg |
79 EUR |
|
Aciclovir for impurity G identification |
0.004 mg |
79 EUR |
|
Aciclovir for impurity C identification CRS |
0.3 mg |
79 EUR |
|
Procaine benzylpenicillin for peak identification A |
15 mg |
79 EUR |
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
Sorbitol CRS |
5 |
1250 mg |
79 EUR |
|
Bleomycin sulfate CRS |
3 |
7 mg |
79 EUR |
|
Betaxolol hydrochloride CRS |
3 |
60 mg |
79 EUR |
|
Streptomycin sulfate CRS |
5 |
100 mg |
79 EUR |
|
Lactulose CRS |
5 |
4120 mg |
79 EUR |
|
Ceftriaxone impurity A CRS |
6 |
10 mg |
79 EUR |
|
Buspirone for system suitability CRS |
4 |
2 mg |
79 EUR |
|
Monoammonium glycyrrhizate CRS |
6 |
300 |
79 EUR |
|
Rocuronium bromide CRS |
2 |
20 mg |
79 EUR |
|
Rosuvastatin for peak identification CRS |
2 |
15 mg |
79 EUR |
Information on reference standards removed from catalogue
None.
Information on reference standards with a future removal from catalogue
Following the implementation of Supplement 10.3, the following standards are officially withdrawn as of 1 January 2021.
Catalogue code |
Name |
Comments |
Y0000055 |
Acamprosate calcium - reference spectrum |
Removed from Ph. Eur. supplement 10.3 (in application from 1 January 2021) but kept on sales for an additional 6 months according to new policy (see “Change in the policy for withdrawing reference standards from sale”). |
F0253000 |
Fluoxetine hydrochloride |
|
O0120010 |
Ofloxacin impurity A |
|
M0400000 |
Meprobamate CRS |
|
Y0000035 |
Carisoprodol CRS |
|
Y0000036 |
Carisoprodol impurity A CRS |
|
N0050000 |
Nalidixic acid CRS |
|
Y0001792 |
Nalidixic acid impurity C CRS |
|
P2800000 |
Prednisolone acetate |
|
Y0000369 |
Primidone for peak identification |
|
Y0000239 |
Celiprolol for peak identification |
|
Y0000312 |
Celiprolol impurity I |
|
B1000000 |
Betamethasone |
|
Y0000883 |
Adrenaline with impurity F |
|
Y0001128 |
Epinastine for system suitability |
These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of June 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 31 December 2021) to allow users to print the batch validity statement (BVS).
Information on change of sales units
None.
Information on change of price
Please note the price change for batch 2 of Everolimus CRS products, i.e. Everolimus for system suitability CRS and Everolimus for impurity C identification CRS, to €300 per sales unit.
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:
- Etodolac for peak identification CRS batch 3 is now stored at –20°C (previously +5 °C) and shipped under Ice –20°C (previously ambient temperature).
Content of the European Pharmacopoeia RS catalogue
The EDQM proposes 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 PDFs).
For your convenience, the Ph. Eur. RS catalogue is published daily and can be downloaded in in PDF format and in XML format.
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 e-mail to [email protected] (in this case, please ensure that your order, on your company letterhead, states both the catalogue code and substance name and is attached to your e-mail).