- 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:
- Content of the Ph. Eur. RS catalogue
- How to place an RS order
- The EDQM helps the users to test some draft texts proposed in Pharmeuropa through Qualified Samples
The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the release of:
|
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
|
Adrenaline CRS |
2 |
15 mg |
79 EUR |
|
|
Carvedilol for system suitability CRS |
4 |
10 mg |
79 EUR |
|
|
Methylprednisolone hydrogen succinate CRS |
4 |
60 mg |
79 EUR |
|
|
Solifenacin for system suitability CRS |
2 |
2.52 mg |
79 EUR |
|
|
Tranexamic acid impurity B CRS |
2 |
15 mg |
79 EUR |
|
|
Bromhexine hydrochloride CRS |
6 |
200 mg |
79 EUR |
|
|
Human immunoglobulin (molecular size) BRP |
3 |
10 mL |
90 EUR |
|
|
Imatinib impurity F CRS |
4 |
15 mg |
79 EUR |
|
|
Pioglitazone hydrochloride CRS |
3 |
120 mg |
79 EUR |
|
|
Testosterone for system suitability A CRS |
2 |
20 mg |
79 EUR |
|
|
Adrenaline impurity mixture CRS |
5 |
0.005 mg |
79 EUR |
|
|
Aspartame impurity A CRS |
6 |
20 mg |
79 EUR |
|
|
Megestrol acetate CRS |
2 |
120 mg |
79 EUR |
|
|
Valaciclovir impurity F para-toluenesulfonate CRS |
2 |
20 mg |
79 EUR |
|
|
Betamethasone valerate for system suitability CRS |
3 |
20 mg |
79 EUR |
|
|
Calcitriol CRS |
13 |
10 mg |
1000 EUR |
|
|
Pregabalin impurity A CRS |
3 |
0.25 mg |
79 EUR |
Information on reference standards removed from catalogue
- Supplement 11.2
Following the implementation of Supplement 11.2, the following standards are officially withdrawn (or replaced) since 1 July 2023.
|
C0249000 |
Calcium ascorbate - reference spectrum (replaced 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 |
|
|
Y0000265 |
Flunarizine dihydrochloride - reference spectrum (replaced by Flunarizine dihydrochloride CRS F0189900) |
Information on reference standards with a future removal from catalogue
- Supplement 11.3
Following the implementation of Supplement 11.3, the following standards will be officially withdrawn (or replaced) from 1 January 2024.
|
Y0002166 |
Donepezil Hydrochloride Monohydrate |
These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 June 2024. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 January 2025) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details. |
|
Y0000679 |
Mepyramine impurity A |
|
|
Y0001288 |
Salbutamol sulfate for system suitability (replaced by Salbutamol for peak identification CRS Y0002386) |
|
|
Y0000030 |
Salbutamol impurity B |
|
|
Y0000071 |
Salbutamol impurity D |
|
|
Y0000031 |
Salbutamol impurity F |
|
|
Y0000034 |
Salbutamol impurity G |
|
|
Y0000032 |
Salbutamol impurity I |
|
|
Y0000371 |
Sestamibi labelling kit (replaced by Sestamibi labelling kit A CRS Y0002420) |
|
|
Y0000115 |
Sotalol impurity B |
|
|
T2200010 |
Trimethoprim impurity B |
|
|
Y0000684 |
Trimethoprim for system suitability (replaced by Trimethoprim for peak identification CRS Y0002392) |
Information on change of sales units
- None
Information on change of amount per unit
- Aspartame impurity A (A1321000) CRS batch 6 contains 20 mg per unit (previously 10 mg)
- Valaciclovir impurity F para-toluenesulfonate (Y0001098) CRS batch 2 contains 20 mg per unit (previously 12 mg)
- Clebopride malate (C2221000) CRS batch 1.3 contains 70mg per unit (previously 100 mg)
- Imatinib impurity F (Y0001693) CRS batch 4 contains 15 mg per unit (previously 10 mg)
- Adrenaline (Y0000882) CRS batch 2 contains 15 mg per unit (previously 5 mg)
Information on change of price
- None
Information on change of EDQM storage/shipping conditions
- None
Information on International Chemical Reference Substances (ICRS) and International Standards for Antibiotics (ISA)
ICRS
- None
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.
The EDQM helps the users to test some draft texts proposed in Pharmeuropa through Qualified Samples
In some cases, ‘qualified samples’ are made available by the EDQM at the time of publication in Pharmeuropa to allow users to check the changes (e.g. to the related substances test) proposed during the public enquiry and best prepare for the implementation of the monograph.
Where a qualified sample is available, it is described in the briefing note of the Pharmeuropa monograph and may be ordered free of charge by raising a request in the EDQM HelpDesk.
After use, users are kindly requested to share their results with the EDQM.
To place an order via the EDQM HelpDesk, please click on European Pharmacopoeia and choose the category Question about General Chapters and Monographs. Providing us with your full shipping address and the title of the corresponding Ph. Eur. monograph, while stating ‘Qualified sample’ in the subject of the query, will help us to rapidly process your request.
For further information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.