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18 replacement batches of Ph. Eur. reference standards released in March 2020

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Reference Standard
Collection & Catalogue
News
03 April 2020
Strasbourg, France

 

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Content of the Ph. Eur. RS catalogue

How to place an RS order

 

The EDQM announces the availability of:

  • 18 replacement batches for European Pharmacopoeia (Ph. Eur.) reference standards:

Catalogue code

Name

Batch

Unit quantity

Y0001802

Entecavir impurity F CRS

3

10 mg

Y0000173

4-Aminobenzoic acid CRS

3

60 mg

A0208000

N-Acetyltryptophan CRS

3

125 mg

G0150000

Gammacyclodextrin CRS

4

120 mg

Y0001070

Amlodipine impurity G CRS

4

10 mg

L0570000

Levothyroxine sodium CRS

5

100 mg

Y0001421

Bifonazole for system suitability CRS

2

10 mg

S0500000

Silicone elastomer CRS

4

2000

Y0001475

Piroxicam for system suitability CRS

6

15 mg

Y0001271

Aciclovir for peak identification 1 CRS

6

0.3 mg

V0100000

Verapamil hydrochloride CRS

2

50 mg

Y0000573

Fluconazole impurity B CRS

6

15 mg

T2501200

Tristearin CRS

2

180 mg

D0733000

Dextran 4 for calibration CRS

2

50 mg

Y0000685

Letrozole CRS

3

80 mg

S2180000

Sulindac CRS

4

100 mg

E0200000

Enterokinase BRP

2

200 mg

Y0002142

Catalpol CRS

2

15 mg

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Information on reference standards removed from catalogue

None

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Information on reference standards with a future removal from catalogue

  • 01/04/2020

Catalogue code

Name

Comments

F0230000

Fluocortolone pivalate CRS

 

N1080000

Nomegestrol acetate CRS

 

P2804000

Prednisolone hexanoate CRS

 

Y0000342

Testosterone for impurity D identification CRS

 

Y0000343

Testosterone for system suitability CRS

Replaced by Y0002174 Testosterone for system suitability A CRS

Y0000570

Clobetasol for peak identification CRS

 

Z2500010

Zolpidem impurity A CRS

 

 

  • 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

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Information on change of sales units

None

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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.

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Information on change of EDQM storage/shipping conditions

None.

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Removal of Unit quantity in RS leaflets

For information, the Unit quantity is removed from the leaflet of the Reference Standard for each batch released after February 2020 as this information is available on the label of the RS container.

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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.

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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).

See more information in the Note to users.

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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 published on a daily basis and can be downloaded in PDF format and in XML format.

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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).

The EDQM will soon be launching a new and improved WebStore for Reference Standards, following up on its most recent user satisfaction survey. More information is available on the EDQM portal.

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