Back 2 new Ph. Eur. reference standards and 16 replacement batches released in August 2023

EDQM Strasbourg, France 08/09/2023
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The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the release of:

  • 2 new European Pharmacopoeia (Ph. Eur.) reference standards:

Catalogue code

Name

Unit quantity

Price

Y0002418

Hypromellose acetate succinate CRS

15 mg

79 EUR

Y0002414

Cabazitaxel impurity FP-A

10 mg

200 EUR

 

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0001177

Dexamethasone for system suitability CRS

3

15 mg

79 EUR

Y0001962

Levetiracetam impurity E CRS

2

15 mg

79 EUR

Y0001457

Melphalan for system suitability CRS

2

10 mg

79 EUR

Y0001087

Tetra-O-acetyl-mannose triflate CRS

3

90 mg

79 EUR

Y0000116

Acamprosate impurity A CRS

3

110 mg

79 EUR

Y0000328

Azelastine impurity D CRS

2

5 mg

79 EUR

Y0001984

Codeine for system suitability - * narc CRS

3

10 mg

79 EUR

Y0002249

Fluticasone propionate for system suitability CRS

2

15 mg

79 EUR

H1600000

Hyoscyamine sulfate CRS

2

80 mg

79 EUR

Y0002109

Pantolactone CRS

2

10 mg

79 EUR

E1100000

Ergosterol CRS

8

20 mg

79 EUR

X0101000

Xylometazoline impurity A CRS

4

15 mg

79 EUR

Y0001625

Salmeterol xinafoate for peak identification CRS

3

15 mg

79 EUR

Y0001360

Betaxolol for peak identification CRS

2

15 mg

79 EUR

Y0000224

Oxfendazole impurity B CRS

3

25 mg

79 EUR

Y0002354

Everolimus for system suitability A

2

10 mg

300 EUR

 

Information on reference standards removed from catalogue

  • Supplement 11.1

Following the implementation of Supplement 11.1, the following standards are officially withdrawn (or replaced) from 1 April 2023.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)

H0837000

L-Homocysteine thiolactone hydrochloride - reference spectrum

Y0000228

Demethylflumazenil - reference spectrum

  • 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 (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

Y0000265

Flunarizine dihydrochloride - reference spectrum (replaced by Flunarizine dihydrocholride 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

  • Oxfendazole impurity B (Y0000224) CRS batch 3 : contains 25mg per unit (previously 10 mg)
  • Hyoscyamine sulfate (H1600000) CRS batch 2 : contains 80mg per unit (previously 100 mg)
  • Tetra-O-acetyl-mannose triflate (Y0001087) CRS batch 3 : contains 90mg per unit (previously 80 mg)
  • Dexamethasone for system suitability (Y0001177) CRS batch 3 : contains 15mg per unit (previously 10 mg)
  • Levetiracetam impurity E (Y0001962) CRS batch 2 : contains 15mg per unit (previously 10 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).

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. 

 

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.