- 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
- Current non-availability
See also:
The EDQM announces the availability of:
6 new European Pharmacopoeia (Ph. Eur.) reference standards:
| Catalogue code |
NAME |
Unit quantity | PRICE |
|---|---|---|---|
|
Fluoxetine hydrochloride for ID and assay CRS |
250 mg |
79 EUR |
|
|
Epinastine for system suitability A CRS |
10 mg |
79 EUR |
|
|
Latanoprost - reference spectrum |
N/A |
79 EUR |
|
|
Latanoprost CRS |
100 mg |
1000 EUR |
|
|
Bambuterol impurity mixture CRS |
0.002 mg |
79 EUR |
|
|
Deferasirox impurity F CRS |
20 mg |
79 EUR |
20 replacement batches for Ph. Eur. reference standards:
|
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
|---|---|---|---|---|
|
Gestodene CRS |
3 |
130 mg |
79 EUR |
|
|
Tamoxifen citrate CRS |
3 |
80 mg |
79 EUR |
|
|
Levocarnitine CRS |
4 |
125 mg |
79 EUR |
|
|
Salbutamol sulfate for system suitability CRS |
4 |
0.4 mg |
79 EUR |
|
|
Aciclovir for peak identification 2 CRS |
6 |
0.004 mg |
79 EUR |
|
|
Interferon gamma-1b CRS |
3 |
0.5 mL |
90 EUR |
|
|
Zoledronic acid impurity B CRS |
2 |
15 mg |
79 EUR |
|
|
Heparin for physico-chemical analysis CRS |
3 |
300 mg |
79 EUR |
|
|
Didanosine impurity A CRS |
2 |
20 mg |
79 EUR |
|
|
Prednisolone CRS |
10 |
110 mg |
79 EUR |
|
|
Flumequine CRS |
2 |
60 mg |
79 EUR |
|
|
Acetylcysteine CRS |
4 |
50 mg |
79 EUR |
|
|
Class 1 residual solvent solution CRS |
8 |
1.4 mL |
79 EUR |
|
|
Ondansetron hydrochloride dihydrate CRS |
5 |
220 mg |
79 EUR |
|
|
Prilocaine impurity B CRS |
2 |
80 mg |
79 EUR |
|
|
Fluorouracil impurity C CRS |
2 |
20 mg |
79 EUR |
|
|
Bisoprolol for system suitability CRS |
5 |
1.003 mg |
79 EUR |
|
|
Clopidogrel for system suitability CRS |
3 |
70 mg |
79 EUR |
|
|
Paroxetine for system suitability CRS |
2 |
0.02 mg |
79 EUR |
|
|
Spectinomycin hydrochloride CRS |
3 |
100 mg |
79 EUR |
Information on reference standards removed from catalogue
02/07/2021
|
Catalogue code |
Name |
Comments |
|---|---|---|
|
C2332000 |
Clomifene citrate for performance test CRS |
Removed from Ph. Eur. supplement 10.2 (in application from 1 July 2020) 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”, 24 January 2020). |
|
Y0001850 |
Oxytetracycline for system suitability CRS |
back to top
Information on reference standards with a future removal from catalogue
Following the implementation of Supplement 10.3, the following standards will be 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
None.
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 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)