- Replacement batches for Ph. Eur. reference standards
- Removal
- Future removal
- Change of sales units
- Information on change of amount per unit
- Information on change of price
- Change of EDQM storage/shipping conditions
- Information on International Chemical Reference Substances (ICRS) and International Standards for Antibiotics (ISA)
See also:
The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the release of:
|
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
|
Bacampicillin hydrochloride CRS |
4 |
120 mg |
79 EUR |
|
|
Econazole for system suitability CRS |
2 |
20 mg |
79 EUR |
|
|
Enoxaparin sodium CRS |
7 |
120 mg |
79 EUR |
|
|
Methylergometrine for system suitability CRS |
2 |
0.53 mg |
79 EUR |
|
|
Oseltamivir impurity B CRS |
4 |
10 mg |
79 EUR |
|
|
Ticagrelor CRS |
2 |
120 mg |
79 EUR |
|
|
Chlorprothixene hydrochloride CRS |
6 |
50 mg |
79 EUR |
|
|
Deferasirox CRS |
2 |
70 mg |
79 EUR |
|
|
Fluorouracil impurity mixture CRS |
3 |
0.0002 mg |
79 EUR |
|
|
Fusidic acid impurity mixture CRS |
3 |
0.048 mg |
79 EUR |
|
|
Acetylsalicylic acid for peak identification CRS |
7 |
10.3 mg |
79 EUR |
|
|
Ondansetron for TLC system suitability CRS |
4 |
20 mg |
79 EUR |
|
|
Picosulfate for system suitability CRS |
3 |
0.5 mg |
79 EUR |
|
|
Lacosamide impurity D CRS |
3 |
10 mg |
79 EUR |
|
|
Tricaprin CRS |
3 |
310 mg |
79 EUR |
|
|
Budesonide for system suitability CRS |
3 |
10 mg |
79 EUR |
|
|
Menthol CRS |
6 |
100 mg |
79 EUR |
|
|
Diclofenac for system suitability CRS |
5 |
1 mg |
79 EUR |
|
|
Plastic additive 11 CRS |
4 |
300 mg |
79 EUR |
|
|
Isoniazid CRS |
2 |
100 mg |
79 EUR |
Information on reference standards removed from catalogue
- 11th edition
Following the implementation of the 11th edition, the following standards are officially withdrawn (or replaced) from 1 January 2023.
|
D0120000 |
Daunorubicinone (replaced by Daunorubicin for system suitability Y0002351) |
These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 July 2023. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 January 2024) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details. |
|
Y0000768 |
Etodolac for peak identification (replaced by Etodolac impurity mixture Y0002335) |
|
|
Y0000363 |
Ciprofibrate for system suitability (replaced by Ciprofibrate for system suitability A Y00002327) |
|
|
D0431000 |
Dequalinium chloride for performance test (replaced by Dequalinium for system suitability Y00002333) |
|
|
D0430000 |
Dequalinium chloride (replaced by Dequalinium chloride for ID Y00002332) |
|
|
M1550000 |
Methylene chloride (replaced by Methylene chloride - reference spectrum Y00002337) |
|
|
Y0002317 |
Marbofloxacin impurity mixture (replaced by Marbofloxacin impurity mixture A) |
|
|
Y0001496 |
Cefoxitin for peak identification |
|
|
C2150000 |
Cholecalciferol for system suitability |
Information on reference standards with a future removal from catalogue
- Supplement 11.1
Following the implementation of Supplement 11.1, the following standards will be officially withdrawn (or replaced) from 1 April 2023.
|
Y0001245 |
Amylmetacresol for peak identification (remplaced by Amylmetacresol for peak identification A Y0002370) |
These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 October 2023. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 April 2024) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details. |
|
Y0000264 |
Diclazuril for veterinary use - reference spectrum (remplaced by Diclazuril Y0002342) |
|
|
Y0000748 |
Tibolone - reference spectrum (remplaced by Tibolone Y0002348) |
|
|
D1500000 |
Diethylstilbestrol |
|
|
D1600000 |
Diethylstilbestrol dimethyl ether |
|
|
D1700000 |
Diethylstilbestrol monomethyl ether |
|
|
Y0002061 |
Everolimus for system suitability (remplaced by Everolimus for system suitability A Y0002354) |
- Supplement 11.2
Following the implementation of Supplement 11.2, the following standards will be officially withdrawn (or replaced) from 1 July 2023.
|
C0249000 |
Calcium ascorbate - reference spectrum (remplaced by Calcium ascorbate dihydrate Y0002379) |
These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 January 2024. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 July 2024) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details. |
|
T1200000 |
Thiopental |
Information on change of sales units
- None.
Information on change of amount per unit
- Menthol (M0350000) CRS batch 6 contains 100 mg per unit (previously 150 mg)
- Prednisolone acetate FPI (Y0000582) CRS batch 1.2 contains 15 mg per unit (previously 10 mg)
- Sucralfate (Y0001324) CRS batch 1.1 contains 20 mg per unit (previously 10 mg)
- Pyridoxine hydrochloride (P4100000) CRS batch 2.1 contains 110 mg per unit (previously 100 mg)
Information on change of price
- None.
Information on change of EDQM storage/shipping conditions
Based on new stability information, storage and shipping conditions have been changed on 15 March 2023 for the following reference standard:
- Ibuprofen for peak identification (Y0000881) CRS batch 11 is stored at –20°C (previously +5°C) and shipped on Ice –20 °C (previously Ambiant).
Information on International Chemical Reference Substances (ICRS) and International Standards for Antibiotics (ISA)
- ICRS
1 replacement batch for International Chemical Reference Substances
|
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
|
Artenimol ICRS |
2 |
210 mg |
70 EUR |
Information on change of amount per unit
- Artenimol ICRS (ICRS1410) CRS batch 2 contains 210 mg per unit (previously 100 mg)
- ISA
- None
Content of the European Pharmacopoeia RS catalogue
The EDQM proposes more than 3 100 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.
When stocks of a given reference standard are low, the EDQM reserves the right to limit the quantities sold to each user to ensure that as many users as possible will receive at least some of the quantities available. Restrictions on quantities are applied at the time the purchase order is received.
Following a request from many users, the quantities allowed in case of sales restrictions now appear in the online catalogue as well as in the catalogue in XML format.
The EDQM is also responsible for the establishment, preparation, storage and distribution of WHO International Chemical Reference Standards (ICRS) and International Standards for Antibiotics (ISA).
If you wish to place an order, you can send your request to the EDQM either:
- via the WebStore;
- 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).
A video has been prepared to help user ordering through the RS WebStore.