Back 1 new Ph. Eur. reference standards and 15 replacement batches released in February 2023

EDQM Strasbourg, France 03/03/2023
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1 new Ph. Eur. reference standards and 15 replacement batches released in February 2023

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

1 new European Pharmacopoeia (Ph. Eur.) reference standards:

Catalogue code

 

 

Name

Unit quantity

Price

Y0002390

Dabigatran etexilate impurity C CRS

10 mg

150 EUR

 

15 replacement batches for Ph. Eur. reference standards:

 

Catalogue code

Name

Batch

Unit quantity

Price

Y0000197

Ondansetron for LC system suitability CRS

2

10 mg

79 EUR

Y0001197

Cetirizine for peak identification CRS

4

1.01 mg

79 EUR

Y0000413

Sulfamethoxazole impurity F CRS

4

15 mg

79 EUR

Y0000108

Trihexyphenidyl hydrochloride CRS

2

80 mg

79 EUR

Y0001291

Iodixanol impurity E CRS

3

10.025 mg

79 EUR

Y0000194

Goserelin validation mixture CRS

3

1 mg

79 EUR

P3850000

Pseudoephedrine hydrochloride CRS - * Drug Precursor

4

50 mg

79 EUR

S0460000

Sertaconazole nitrate CRS

3

125 mg

79 EUR

Y0001895

Teriparatide for system suitability CRS

2

1.3 mg

79 EUR

Y0000806

Arbutin CRS

3

110 mg

79 EUR

Y0002048

Everolimus CRS

2

70 mg

300 EUR

Y0001663

Human coagulation factor VIIa (rDNA) CRS

2

42 mg

79 EUR

Y0002167

Rosuvastatin impurity mixture CRS

2

0.002 mg

79 EUR

E2205500

1,1'-Ethylidenebistryptophan CRS

9

0.002 mg

79 EUR

F0372000

Formoterol fumarate dihydrate CRS

3

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Following the implementation of the 11th edition, the following standards are officially withdrawn (or replaced) from 1 January 2023.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

  • Formoterol fumarate dihydrate (F0372000) CRS batch 3 contains 15 mg per unit (previously 10 mg)
  • Trihexyphenidyl hydrochloride (Y0000108) CRS batch 2 contains 80 mg per unit (previously 100 mg)
  • Sulfamethoxazole impurity F (Y0000413) CRS batch 4 contains 15 mg per unit (previously 5 mg)

Information on change of price

  • None.

Information on change of EDQM storage/shipping conditions

  • 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. 

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.