Back 20 replacement batches released in March 2023

EDQM STRASBOURG, FRANCE 04/04/2023
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20 replacement batches released in March 2023

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

  • 20 replacement batches for Ph. Eur. reference standards:

Catalogue code

Name

Batch

Unit quantity

Price

B0070000

Bacampicillin hydrochloride CRS

4

120 mg

79 EUR

Y0000254

Econazole for system suitability CRS

2

20 mg

79 EUR

E0180000

Enoxaparin sodium CRS

7

120 mg

79 EUR

Y0000777

Methylergometrine for system suitability CRS

2

0.53 mg

79 EUR

Y0001339

Oseltamivir impurity B CRS

4

10 mg

79 EUR

Y0002222

Ticagrelor CRS

2

120 mg

79 EUR

C1915000

Chlorprothixene hydrochloride CRS

6

50 mg

79 EUR

Y0002196

Deferasirox CRS

2

70 mg

79 EUR

Y0000791

Fluorouracil impurity mixture CRS

3

0.0002 mg

79 EUR

Y0001384

Fusidic acid impurity mixture CRS

3

0.048 mg

79 EUR

Y0001460

Acetylsalicylic acid for peak identification CRS

7

10.3 mg

79 EUR

Y0000196

Ondansetron for TLC system suitability CRS

4

20 mg

79 EUR

Y0001104

Picosulfate for system suitability CRS

3

0.5 mg

79 EUR

Y0002065

Lacosamide impurity D CRS

3

10 mg

79 EUR

T1977990

Tricaprin CRS

3

310 mg

79 EUR

Y0001148

Budesonide for system suitability CRS

3

10 mg

79 EUR

M0350000

Menthol CRS

6

100 mg

79 EUR

Y0001635

Diclofenac for system suitability CRS

5

1 mg

79 EUR

P2155011

Plastic additive 11 CRS

4

300 mg

79 EUR

I0500000

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Following the implementation of the 11th edition, the following standards are officially withdrawn (or replaced) from 1 January 2023.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

ICRS1410

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).

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 [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.