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5 new reference standards and 17 replacement batches released in January 2021

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Actualité
03 février 2021
Strasbourg, France

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The EDQM announces the availability of:

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

Catalogue code

Name

Unit quantity

Price

Y0002247

Teriflunomide CRS

15 mg

150 EUR

Y0002253

Teriflunomide for assay

50 mg

300 EUR

Y0002254

Teriflunomide impurity B

15 mg

79 EUR

Y0002252

Clomifene for impurities G and H identification

20 mg

79 EUR

Y0002248

Ibandronate sodium monohydrate CRS

15 mg

79 EUR

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

Catalogue code

Name

Batch

Unit quantity

Price

E1310000

Erythromycin B CRS

5

25 mg

79 EUR

H1115000

Hyaluronidase BRP

3

50 mg

79 EUR

D0300000

Demeclocycline hydrochloride CRS

5

100 mg

79 EUR

Y0001820

Methacrylic acid - methylmethacrylate copolymer (1:1) CRS

2

120 mg

79 EUR

C2150000

Cholecalciferol for system suitability CRS

10

1 mL

79 EUR

Y0000574

Fluconazole impurity C CRS

6

20 mg

79 EUR

Y0001568

Isoquercitroside CRS

2

20 mg

79 EUR

Y0000568

Cefradine for peak identification CRS

4

15 mg

79 EUR

C2170000

Cilastatin sodium CRS

3

25 mg

79 EUR

Y0001984

Codeine for system suitability - * narc CRS

2

10 mg

79 EUR

Y0001379

Levonorgestrel impurity B CRS

3

15 mg

79 EUR

Y0000599

Midazolam for system suitability CRS - * psy (Midazolam)

4

1 mg

79 EUR

T1977995

Tricaproin CRS

2

40 mg

79 EUR

B1170000

Busulfan CRS

4

50 mg

79 EUR

Y0000316

Mesna impurity C CRS

3

15 mg

79 EUR

R0700000

Rifampicin CRS

3

100 mg

79 EUR

Y0001769

Pirfenidone CRS

2

120 mg

79 EUR

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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Following the implementation of Supplement 10.3, the following standards are officially withdrawn from 1 January 2021.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

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Information on reference standards with a future removal from catalogue

  • Supplement 10.4

Following the implementation of Supplement 10.4 (1 April 2021), the following standards will be removed from the catalogue:

Erythromycin for impurity M identification

Y0001846

Amobarbital - * psy

A0650000

Amobarbital sodium - * psy

A0700000

Desmethylmetrifonate

D0630000

Metrifonate

M1845000

 

The following standards will also be removed and replaced:

Items removed

Catalogue code

Replaced by

Catalogue code

Atorvastatin impurity A

Y0001328

Atorvastatin for system suitability

Y0002229

Atorvastatin impurity B
Y0001329
Atorvastatin for system suitability
Y0002229

Atorvastatin impurity C

Y0001330

Atorvastatin for system suitability

Y0002229

Atorvastatin impurity D

Y0001331

Atorvastatin for system suitability

Y0002229

Aciclovir for system suitability

Y0001264

Aciclovir for system suitability A

Y0002245

Fluticasone propionate for impurity G identification

Y0001755

Fluticasone propionate for system suitability

Y0002249

Aciclovir for peak identification 1

Y0001271

Aciclovir for impurity C identification

Y0002242

Procaine benzylpenicillin for peak identification

Y0002077

Procaine benzylpenicillin impurity F

Y0002171

Aciclovir for peak identification 2

Y0001269

Aciclovir for impurity G identification

Y0002244

NB 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.

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  • 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

Y0002266

Ciclosporin for system suitability

Y0000361

Ciclosporin for system suitability A

Catalogue code not yet known

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.

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Information on change of sales units

None.

 

Information on change of price

Please note the price change for Batch 2 of Everolimus CRS products, i.e. Everolimus for system suitability 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, storage and shipping conditions will be simplified on 15 February 2021 for the following reference standard:

  • Simvastatin (S0650000) CRS batch 6 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C).

In order to ensure better stability, storage and shipping conditions will be changed on 15 February 2021 for the following reference standard:

  • Flupentixol for system suitability CRS (Y0002094) batch 1 will be stored at –20 °C (previously +5 °C) and shipped under Ice –20 °C (previously 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.

 

How to place an RS order

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 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).

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