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18 replacement batches released in May 2019

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11 June 2019
Strasbourg, France

The EDQM announces the availability of:

  • 18 Replacement batches for Ph. Eur. Reference Standards:

Y0001811

Sitagliptin containing impurity A

Y0000853

Fluvoxamine for system suitability

H1500000

Hyoscine hydrobromide

Y0001250

Entacapone impurity A

Y0001094

Aceclofenac for peak identification

Y0000596

Diazepam for system suitability - * psy

Y0000400

Naltrexone hydrochloride

Y0001242

Folic acid impurity A

Y0000391

Betahistine dihydrochloride

I0800000

Isotretinoin

Y0001757

Bromhexine for system suitability

Y0001399

Fulvestrant

Y0000626

Ketorolac trometamol for peak identification

M1824995

Metoclopramide impurity A

E2499900

Etofenamate

Y0000334

Codeine impurity A

Y0001800

Entecavir monohydrate

Y0000288

Piracetam

 

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.

Content of the European Pharmacopoeia RS catalogue

The EDQM proposes more than 2900 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 European Pharmacopoeia (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 here as well as in XML format here.

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 email to orders@edqm.eu (in this case, please ensure that your order is on your company letter headed paper stating both the catalogue code and substance name and attached to your email).
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