- 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:
|
Catalogue code |
Name |
Unit quantity |
Price |
|---|---|---|---|
|
Fluticasone furoate CRS |
70 mg |
79 EUR |
|
|
Nitrofural for peak identification A |
0.11 mg |
79 EUR |
|
|
Pravastatin 1,1,3,3-tetramethylbutylamine for assay |
30 mg |
79 EUR |
|
|
Croscarmellose sodium CRS |
20 mg |
79 EUR |
|
|
Dipotassium clorazepate monohydrate-*psy |
15 mg |
79 EUR |
|
|
Flurbiprofen for peak identification CRS |
20 mg |
79 EUR |
|
|
Somatostatin impurity F CRS |
0.01 mg |
90 EUR |
|
Catalogue code |
Name |
Batch |
Unit quantity |
Price |
|---|---|---|---|---|
|
Tianeptine impurity A CRS |
2 |
80 mg |
79 EUR |
|
|
Arginine hydrochloride CRS |
4 |
60 mg |
79 EUR |
|
|
Biotin CRS |
4 |
20 mg |
79 EUR |
|
|
Doxazosin impurity D CRS |
2 |
15 mg |
79 EUR |
|
|
Fluorouracil impurity B CRS |
2 |
15 mg |
79 EUR |
|
|
Hydralazine hydrochloride CRS |
2 |
20 mg |
79 EUR |
|
|
Ramipril impurity A CRS |
5 |
20 mg |
79 EUR |
|
|
Triflusal impurity B CRS |
2 |
15 mg |
79 EUR |
|
|
Valaciclovir hydrochloride (anhydrous) CRS |
2 |
210 mg |
79 EUR |
|
|
Cilastatin sodium CRS |
4 |
25 mg |
79 EUR |
|
|
Ibuprofen for peak identification CRS |
10 |
0.09 mg |
79 EUR |
|
|
Meloxicam impurity D CRS |
4 |
20 mg |
79 EUR |
|
|
Trolamine impurity A CRS |
3 |
250 mg |
79 EUR |
|
|
Codeine CRS - * narc (Codeine monohydrate) |
2 |
25 mg |
79 EUR |
|
|
Dinoprost trometamol CRS |
2 |
60 mg |
79 EUR |
|
|
Human immunoglobulin for Fc function BRP |
2 |
10 mL |
90 EUR |
|
|
Lactobionic acid CRS |
3 |
100 mg |
79 EUR |
|
|
Ascorbic acid CRS |
5 |
70 mg |
79 EUR |
|
|
Aciclovir for system suitability CRS |
2 |
20 mg |
79 EUR |
|
|
Oxaliplatin impurity C CRS |
7 |
20 mg |
79 EUR |
|
|
Tranexamic acid CRS |
6 |
20 mg |
79 EUR |
|
|
Aescin for LC assay HRS |
2 |
150 mg |
79 EUR |
|
|
Betacarotene CRS |
3 |
110 mg |
79 EUR |
|
|
Diltiazem hydrochloride CRS |
6 |
100 mg |
79 EUR |
|
|
Ketoprofen impurity A CRS |
7 |
15 mg |
79 EUR |
|
|
Mefenamic acid CRS |
3 |
50 mg |
79 EUR |
Information on reference standards removed from catalogue
- Supplement 10.3
Following the implementation of Supplement 10.3, the following standards are officially withdrawn from 1 January 2021.
|
Catalogue code |
Name |
Comments |
|---|---|---|
|
Y0000055 |
Acamprosate calcium - reference spectrum |
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). See “Change in the policy for withdrawing reference standards from sale” for more details. |
|
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 |
|
|
Y0000369 |
Primidone for peak identification |
|
|
Y0000239 |
Celiprolol for peak identification |
|
|
Y0000312 |
Celiprolol impurity I |
|
|
Y0000883 |
Adrenaline with impurity F |
|
|
Y0001128 |
Epinastine for system suitability |
- Supplement 10.4
Following the implementation of Supplement 10.4, the following standards are officially withdrawn from 1 April 2021.
|
Catalogue code |
Name |
Comments |
|---|---|---|
|
Y0001846 |
Erythromycin for impurity M identification |
These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of September 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 31 March 2022) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details. |
|
A0650000 |
Amobarbital - * psy |
|
|
A0700000 |
Amobarbital sodium - * psy |
|
|
D0630000 |
Desmethylmetrifonate |
|
|
M1845000 |
Metrifonate |
|
|
Y0001328 |
Atorvastatin impurity A |
|
|
Y0001329 |
Atorvastatin impurity B |
|
|
Y0001330 |
Atorvastatin impurity C |
|
|
Y0001331 |
Atorvastatin impurity D |
|
|
Y0001264 |
Aciclovir for system suitability |
|
|
Y0001755 |
Fluticasone propionate for impurity G identification |
|
|
Y0001271 |
Aciclovir for peak identification 1 |
|
|
Y0002077 |
Procaine benzylpenicillin for peak identification |
|
|
Y0001269 |
Aciclovir for peak identification 2 |
Information on reference standards with a future removal from catalogue
- Supplement 10.5
Following the implementation of Supplement 10.5 (1 July 2021), the following standards will be removed from the catalogue:
|
Diflunisal |
D1750000 |
|
Codeine impurity A (O-methylcodeine) |
Y0000334 |
|
Theobromine |
T0700000 |
The following standards will also be removed and replaced:
|
Items removed |
Catalogue code |
Replaced by |
Catalogue code |
|---|---|---|---|
|
Zidovudine for system suitability |
Y0001641 |
Zidovudine for system suitability A |
|
|
Ciclosporin for system suitability |
Y0000361 |
Ciclosporin for system suitability A |
NB These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of December 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 30 June 2022) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.
Information on change of sales units
None.
Information on change of price
Please note the price change for Batch 2 of Everolimus 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, shipping conditions were simplified on 17 May 2021 for the following reference standards:
|
Name |
Catalogue Code |
Batch |
Current shipping conditions |
New shipping conditions |
|---|---|---|---|---|
|
Equine influenza subtype 1 strain A/eq/Newmarket/77 h a BRP |
E0850010 |
2 |
Ice –20 |
Ambient temp. |
|
Equine influenza subtype 2 American-like/Newmarket/1/93 h a BRP |
E0850021 |
2 |
||
|
Equine influenza subtype 2 European-like/Newmarket/2/93 h a BRP |
E0850022 |
2 |
||
|
Equine influenza subtype 2 American-like/South Africa/4/03 h a BRP |
Y0000712 |
1 |
||
|
Equine influenza subtype 2 American-like strain A/Eq/Richmond/1/2007 h |
Y0001874 |
1 |
||
|
Bordetella pertussis mouse antiserum BRP |
B1142000 |
2 |
||
|
Etanercept BRP |
Y0002042 |
1 |
||
|
Infliximab BRP |
Y0002110 |
1 |
||
|
Human tetanus immunoglobulin BRP |
H1110000 |
2 |
||
|
Tetanus vaccine BRP |
T0400000 |
3 |
||
|
Endotoxin standard BRP |
E0150000 |
5 |
||
|
Erythropoietin BRP |
E1515000 |
5 |
||
|
Erythropoietin for physicochemical tests BRP |
Y0001725 |
1 |
||
|
Erythropoietin for SEC BRP |
Y0002009 |
1 |
||
|
Human coagulation factor VII concentrate BRP |
Y0000667 |
2 |
Please note that due to their stability profile these standards may be shipped at ambient temperature, but that they should be stored at –20°C upon receipt.
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.
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 quantity allowed for each user is now directly displayed in the detailed view of the online catalogue.
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).