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10 new reference standards and 22 replacement batches released in September 2020

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Reference Standard
Collection & Catalogue
News
06 October 2020
Strasbourg, France

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The EDQM announces the availability of:

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

Catalogue code

Name

Unit quantity

Price

Y0002238

Riociguat CRS

1

130 mg

A0350030

Allopurinol impurity C CRS

1

15 mg

Y0002249

Fluticasone propionate for system suitability CRS

1

15 mg

Y0002240

Riociguat for FP system suitability CRS

1

15 mg

Y0002239

Riociguat for system suitability CRS

1

15 mg

Y0002228

Regorafenib impurity FP-C CRS

1

20 mg

Y0002227

Regorafenib impurity FP-B CRS

1

15 mg

Y0002225

Regorafenib for FP system suitability CRS

1

10 mg

Y0002241

Piperacillin impurity N CRS

1

15 mg

Y0002194

Pentobarbital sodium CRS - * psy

1

40 mg

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0001305

Cefpodoxime proxetil CRS

2

80 mg

79 EUR

Y0001488

Methyl methacrylate CRS

2

50 mg

79 EUR

Y0001847

Erythromycin for system suitability CRS

2

15 mg

79 EUR

F0048000

Fenofibrate CRS

4

100 mg

79 EUR

Y0001168

Potassium clavulanate impurity G CRS

4

5 mg

79 EUR

Y0001785

Dienogest CRS

2

80 mg

79 EUR

Y0001436

Montelukast dicyclohexylamine CRS

3

150 mg

79 EUR

Y0001783

Rabeprazole sodium hydrate CRS

2

150 mg

79 EUR

Y0000881

Ibuprofen for peak identification CRS

9

0.09 mg

79 EUR

Y0000507

Chlorpromazine impurity A CRS

3

15 mg

79 EUR

O0500000

Oxytetracycline hydrochloride CRS

6

20 mg

79 EUR

Y0001280

Gabapentin CRS

3

400 mg

79 EUR

Y0000145

Metoprolol impurity A CRS

5

15 mg

79 EUR

N0399000

Neohesperidin-dihydrochalcone CRS

3

125 mg

79 EUR

C2600000

Colistimethate sodium CRS

3

26.2 mg

79 EUR

Y0000795

Glycerol monocaprylocaprate CRS

3

500

79 EUR

Y0000319

Propylene glycol monolaurate CRS

2

100 mg

79 EUR

Y0001620

2,4-Dichlorobenzyl alcohol CRS

2

250 mg

79 EUR

C2155000

Cholesterol CRS

5

80 mg

79 EUR

Y0001225

Valaciclovir for system suitability CRS

2

10 mg

79 EUR

Y0001417

Tadalafil CRS

3

200 mg

79 EUR

Y0001014

Amphotericin B for peak identification CRS

4

10 mg

79 EUR

Information on reference standards removed from catalogue

None.

Information on reference standards with a future removal from catalogue

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

Catalogue code

Name

Comments

Y0000055

Acamprosate calcium - reference spectrum

Removed from Ph. Eur. supplement 10.3 (in application from 1 January 2021) but kept on sales for an additional 6 months according to EDQM policy (see news bulletin “Change in the policy for withdrawing reference standards from sale”).

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

P2800000

Prednisolone acetate

Y0000369

Primidone for peak identification

Y0000239

Celiprolol for peak identification

Y0000312

Celiprolol impurity I

B1000000

Betamethasone

Y0000883

Adrenaline with impurity F

Y0001128

Epinastine for system suitability

 

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).

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 October 2020 for the following reference standard:

  • Calcipotriol FSS (Y0002041) CRS batch 1 will be stored at +5°C (previously -20°C) and shipped at ambient temperature (previously Ice -20°C).

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 PDF).

For your convenience, the Ph. Eur. RS catalogue is updated on a daily basis and can be downloaded 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).
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