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7 new Ph. Eur. reference standards and 14 replacement batches released in May 2020

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Reference Standard
Collection & Catalogue
News
04 June 2020
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

Y0002215

Primidone for system suitability CRS

10 mg

79 EUR

Y0002204

Cyanocobalamin for system suitability

15 mg

79 EUR

Y0002203

Cyanocobalamin for peak identification CRS

15 mg

79 EUR

Y0002192

Amprolium hydrochloride

50 mg

79 EUR

Y0002186

Dronedarone impurity A CRS

10 mg

79 EUR

Y0002183

Isovitexin HRS

15 mg

150 EUR

Y0002187

Rivaroxaban CRS

100 mg

79 EUR

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0001080

Meloxicam CRS

2

50 mg

79 EUR

Y0001804

Gadobutrol for peak identification CRS

2

20 mg

79 EUR

Y0001435

Montelukast for peak identification CRS

4

20 mg

79 EUR

Y0000862

Mianserin for system suitability CRS

2

1.01 mg

79 EUR

Y0000424

Atracurium besilate CRS

4

120 mg

79 EUR

Y0000041

Josamycin CRS

3

150 mg

79 EUR

T2600000

Trypsin BRP

3

100 mg

79 EUR

Y0000685

Letrozole CRS

4

80 mg

79 EUR

Y0000321

Clarithromycin for peak identification CRS

4

10 mg

79 EUR

Y0000161

Ketotifen impurity G CRS

6

0.0225 mg

79 EUR

Y0001749

Thiamine for system suitability CRS

3

0.5 mg

79 EUR

Y0000012

Hymecromone impurity A CRS

2

25 mg

79 EUR

B1160000

Bupivacaine hydrochloride CRS

3

100 mg

79 EUR

Y0000858

Isoflurane CRS

3

1.4 mL

79 EUR

 

Information on reference standards removed from catalogue

None.

 

Information on reference standards with a future removal from catalogue

  • 02/07/2021
Catalogue code Name Comments
C2332000 Clomifene citrate for performance test CRS

Removed from Ph. Eur. supplement 10.2 (in application from 01/07/2020) but kept on sales for an additional 6 months according to new policy (see “Change in the policy for withdrawing reference standards from sale”).

Y0001850 Oxytetracycline for system suitability CRS

 

Information on change of sales units

None.

 

Information on change of price

Please note that the price for Everolimus CRS, Everolimus for system suitability CRS and Everolimus for impurity C identification CRS Batch 2 has changed to €300.

 

Information on change of EDQM storage/shipping conditions

Based on new stability information, storage and shipping conditions will be simplified on 15/06/2020 for the following reference standards:

  • Nilotinib for system suitability CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C);
  • Nilotinib impurity A CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C);
  • Nilotinib impurity B CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C);
  • Nilotinib impurity C CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C);
  • Simvastatin for system suitability CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C).

 

Change in the policy for withdrawing reference standards from sale

A new policy will be applied from the application of Supplement 10.2 (01/07/2020). Detailed information is available in the news item of 24 January 2020.

 

Information on the current non-availability of a reference standard

Ph. Eur. Somatropin/Desamidosomatropin resolution mixture CRS (Y0000711) is currently unavailable.

In order to overcome the temporary shortage of this CRS and until the replacement batch is made available, it is advised to prepare the system suitability resolution solution for the test of related proteins described in the monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin) and 0952 (Somatropin for injection) by using the Ph. Eur. Somatropin CRS Batch 3 (Cat. No. S0947000).

Find more information in the Note to users.

 

Content of the European Pharmacopoeia RS catalogue

The EDQM proposes more than 3 000 Ph. Eur. RSs, 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. RSs, but also to:

  • Batch Validity Statements (BVSs) for each reference standard;
  • Safety Data Sheets and Safety Data Statements for hazardous biologicals;
  • leaflets (downloadable as PDFs).

For your convenience, the Ph. Eur. RS catalogue is published 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 and is attached to your e-mail).
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