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7 new reference standards and 30 replacement batches released in February 2021

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News
04 March 2021
Strasbourg, France

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The EDQM announces the availability of:

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

Catalogue code

Name

Unit quantity

Price

Y0002292

Ciclosporin for system suitability A

1 mg

79 EUR

Y0002267

Ethanolamine CRS

30 mg

79 EUR

Y0002275

Oxybutynin hydrochloride for system suitability CRS

15 mg

79 EUR

Y0002289

Dipotassium clorazepate monohydrate - reference spectrum

1

79 EUR

Y0002268

Beta-sitosterol for peak identification

10 mg

79 EUR

Y0002286

Terazosin for system suitability A

0.59 mg

79 EUR

Y0002266

Zidovudine for system suitability A CRS

10 mg

79 EUR

 

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0000472

Cabergoline CRS

3

170 mg

79 EUR

Y0000090

Finasteride CRS

4

130 mg

79 EUR

B1220000

Ibuprofen impurity B CRS

10

1.15 mL

79 EUR

Y0001574

Mesalazine for system suitability CRS

6

10 mg

79 EUR

Y0001444

Bicalutamide CRS

2

160 mg

79 EUR

I0020000

Ibuprofen CRS

6

150 mg

79 EUR

Y0001221

Captopril impurity D CRS

3

15 mg

79 EUR

C2000000

Chlortetracycline hydrochloride CRS

6

100 mg

79 EUR

C2430000

Clotrimazole CRS

5

100 mg

79 EUR

Y0000438

Coumarin CRS

2

160 mg

79 EUR

D0737000

Dextran 250 for calibration CRS

2

50 mg

79 EUR

Y0002061

Everolimus for system suitability CRS

2

10 mg

300 EUR

P1890000

Piperacillin CRS

6

100 mg

79 EUR

Y0002006

Sulfobutylbetadex impurity D CRS

2

40 mg

79 EUR

B1030000

Betamethasone acetate CRS

4

100 mg

79 EUR

Y0000816

Atropine impurity B CRS

3

10 mg

79 EUR

Y0001339

Oseltamivir impurity B CRS

3

10 mg

79 EUR

Y0001219

Captopril impurity B CRS

3

15 mg

79 EUR

Y0001635

Diclofenac for system suitability CRS

4

1 mg

79 EUR

G0325000

Glibenclamide CRS

4

50 mg

79 EUR

Y0001419

Quetiapine for system suitability CRS

4

2 mg

79 EUR

B1121000

Biperiden impurity A CRS

3

20 mg

79 EUR

Y0001459

Triamcinolone acetonide for system suitability CRS

3

10 mg

79 EUR

A0152000

Acetylcysteine impurity C CRS

12

10 mg

79 EUR

D0700000

Dexamethasone CRS

6

70 mg

79 EUR

D0734000

Dextran 10 for calibration CRS

2

50 mg

79 EUR

Y0001536

Fludarabine for system suitability CRS

2

20 mg

79 EUR

Y0000708

Fluphenazine impurity mixture CRS

2

0.07 mg

79 EUR

G0326004

Gliclazide impurity B CRS

5

50 mg

79 EUR

Y0001945

Paracetamol impurity J CRS

2

15 mg

79 EUR

 

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

 

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.

 

  • 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.

Information on change of sales units

None.

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

None.

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.

NEW: A button giving direct access to the web store has been added in the detailed view of each reference standard (below the BVS print button).

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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