- New releases
- Replacement batches for Ph. Eur. reference standards
- Removal
- Future removal
- Change of sales units
- Change of price
- Change of EDQM storage/shipping conditions
See also:
The EDQM announces the availability of:
- 5 new European Pharmacopoeia (Ph. Eur.) reference standards:
Catalogue code |
Name |
Unit quantity |
Price |
Piperacillin impurity I CRS |
15 mg |
79 EUR |
|
Atorvastatin for system suitability CRS |
15 mg |
79 EUR |
|
Streptomycin sulfate for identification |
25 mg |
79 EUR |
|
Adrenaline impurity F CRS |
0.008 mg |
79 EUR |
|
Ketoconazole impurity mixture CRS |
0.03 mg |
79 EUR |
- 21 replacement batches for Ph. Eur. reference standards:
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
---|---|---|---|---|
Insulin glargine CRS |
6 |
15 mg |
79 EUR |
|
Atropine for peak identification CRS |
4 |
0.25 mg |
79 EUR |
|
Roxithromycin CRS |
6 |
125 mg |
79 EUR |
|
Filgrastim CRS |
3 |
0.3 mL |
79 EUR |
|
Ciprofloxacin hydrochloride for peak identification CRS |
4 |
10 mg |
79 EUR |
|
Ubidecarenone impurity D CRS |
3 |
5 mg |
79 EUR |
|
Interferon beta-1a CRS |
4 |
0.6 mL |
90 EUR |
|
Benserazide impurity C CRS |
2 |
15 mg |
79 EUR |
|
Somatropin/desamidosomatropin resolution mixture CRS |
2 |
3 mg |
150 EUR |
|
Trimebutine for system suitability CRS |
3 |
1.02 mg |
79 EUR |
|
Salbutamol impurity J CRS |
4 |
0.00045 mg |
79 EUR |
|
Phenoxymethylpenicillin potassium CRS |
5 |
260 mg |
79 EUR |
|
Morphine sulfate - * narc CRS |
2 |
40 |
79 EUR |
|
Losartan for system suitability CRS |
4 |
0.0015 mg |
79 EUR |
|
Rocuronium for peak identification CRS |
2 |
10 mg |
79 EUR |
|
Ciprofloxacin impurity A CRS |
6 |
25 mg |
79 EUR |
|
Marrubiin CRS |
2 |
15 mg |
79 EUR |
|
Hydroxychloroquine sulfate CRS |
2 |
70 mg |
79 EUR |
|
Levothyroxine for peak identification CRS |
2 |
10 mg |
79 EUR |
|
Phenylephrine CRS |
3 |
50 mg |
79 EUR |
|
Netilmicin sulfate CRS |
2 |
25 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Following the implementation of Supplement 10.3, the following standards are officially withdrawn as of 1 January 2021.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 EDQM policy (see news bulletin “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
Based on new stability information, storage and shipping conditions will be simplified on 15 September 2020 for the following reference standard:
- Cefepime impurity E CRS batch 2 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C).
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 European Pharmacopoeia. 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 updated on a daily basis and can be downloaded 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)