null 3 new Ph. Eur. reference standards and 23 replacement batches released in July 2022

EDQM Strasbourg, France 01/08/2022
3 new Ph. Eur. reference standards and 23 replacement batches released in July 2022

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The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the release of:

  • 3 new batches for Ph. Eur. reference standards:

Catalogue code

Name

Unit quantity

Price

Y0002334

Diosmin for Sheperd's purse CRS

40 mg

79 EUR

Y0002330

Melatonin for system suitability CRS

0.5 mg

79 EUR

Y0002336

Levomepromazine for system suitability CRS

15 mg

79 EUR

 

23 replacement batches for Ph. Eur. reference standards:

Catalogue code

Name

Batch

Unit quantity

Price

Y0001944

Tigecycline impurity B CRS

2

15 mg

79 EUR

Y0000166

Tribenoside impurity A CRS

5

70 mg

79 EUR

B1045000

Betamethasone sodium phosphate CRS

5

100 mg

79 EUR

Y0001448

Bicalutamide for system suitability CRS

3

10 mg

79 EUR

B1153000

Brompheniramine maleate CRS

3

50 mg

79 EUR

Y0000708

Fluphenazine impurity mixture CRS

3

n/a

79 EUR

Y0001292

Iodixanol impurity C CRS

2

10 mg

79 EUR

N0401000

Neomycin sulfate for microbiological assay CRS

7

25 mg

79 EUR

Y0000592

Thioctic acid for system suitability CRS

3

15 mg

79 EUR

Y0002328

Cholecalciferol impurity A CRS

2

0.06 mg

79 EUR

Y0001869

Chloramphenicol for peak identification CRS

2

15 mg

79 EUR

Y0001472

Coagulation Factors V, VIII, XI and XIII plasma BRP

2

1 mg

90 EUR

Y0001994

Human immunoglobulin for anticomplementary activity BRP

3

10 g

79 EUR

S0947000

Somatropin CRS

4

55 mg

150 EUR

D0600000

Deslanoside CRS

4

160 mg

79 EUR

Y0000204

Pravastatin 1,1,3,3-tetramethylbutylamine CRS

3

30 mg

79 EUR

Y0001789

Thiocolchicoside hydrate CRS

2

60 mg

79 EUR

Y0001588

Atomoxetine impurity B CRS

2

10 mg

79 EUR

C0250000

Calcium folinate CRS

9

110 mg

79 EUR

Y0000033

Carbamazepine impurity A CRS

7

20 mg

79 EUR

Y0000349

Insulin aspart CRS

5

8 mg

90 EUR

S2151000

Sulfanilamide CRS

3

100 mg

79 EUR

T2600000

Trypsin BRP

3

100 mg

79 EUR

 

Information on reference standards removed from catalogue

  • Supplement 10.7

Following the implementation of Supplement 10.7, the following standards are officially withdrawn from 1 April 2022.

Y0001327

Atorvastatin calcium trihydrate

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 October 2022. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 April 2023) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0001332

Atorvastatin impurity E

Y0000340

Formoterol fumarate for system suitability

Y0000820

Marbofloxacin for peak identification

Y0002229

Atorvastatin for system suitability

Y0001478

Thiopental for system suitability

Y0002137

Alfacalcidol for impurity B identification

S0400000

Senna extract CRS

D2630000

Diphenoxylate hydrochloride - reference spectrum

Y0001942

Gonadorelin for system suitability

 

  • Supplement 10.8

Following the implementation of Supplement 10.8, the following standards are officially withdrawn from 1 July 2022.

Y0000645

Bromazepam for system suitability

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 January 2023. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 July 2023) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0001005

Dydrogesterone impurity A

 

Information on reference standards with a future removal from catalogue

  • 11th edition

Following the implementation of the 11th edition (11.0), the following standards will be officially withdrawn (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)

C2150000

Cholecalciferol for system suitability

 

Information on change of sales units

  • Not applicable.

Technical information

Due to a quality issue, the distribution of Cholecalciferol for system suitability CRS 11 has been suspended. Users still having this CRS may nevertheless use it.

Cholecalciferol for system suitability CRS is referred to in 3 monographs:

  • Ph. Eur. monograph 0072 for Cholecalciferol
  • Ph. Eur. monograph 0575 for Cholecalciferol concentrate (oily form)
  • Ph. Eur. monograph 0574 for Cholecalciferol concentrate (powder form)

Revised versions of the monographs have been published in the 11th Edition – implementation date: 1 January 2023.

In these revised monographs, Cholecalciferol for system suitability CRS is replaced by a preparation composed of Cholecalciferol CRS and Cholecalciferol impurity A CRS.

Users are advised to immediately implement the revised versions of the monographs. A copy of the latter can be provided to users upon request.

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 modified on 15 July 2022 for the following reference standard:

  • Fenoterol for system suitability (Y0002102) CRS batch 1 is shipped on Ice+5°C (previously at ambient temperature).

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 quantities allowed in case of sales restrictions now appear in the online catalogue as well as in the catalogue 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 WebStore;
  • or by e-mail to orders@edqm.eu (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.