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4 new Ph. Eur. Reference Standards (RS) and 21 replacement batches released in March 2019

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09 April 2019
Strasbourg, France

The EDQM announces the availability of:

  • 4 New Ph. Eur. Reference Standards:

Y0002046 Griseofulvin for LC assay and identification, Y0002061 Everolimus for system suitability, Y0002090 Regorafenib monohydrate, Y0002097 Nilotinib hydrochloride monohydrate.

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

E0100000 Emetine hydrochloride, E2205500 1,1'-Ethylidenebistryptophan, I0361000 Ipratropium impurity B, O0700000 Oxytocin, O0770000 Oxytocin/Desmopressin validation mixture, T1500000 Tobramycin, Y0000133 Clomipramine impurity D, Y0000203 Mexiletine impurity D, Y0000261 Dextromethorphan impurity A, Y0000316 Mesna impurity C, Y0000487 Leflunomide impurity A, Y0000664 Methotrexate impurity E, Y0000671 Capsaicin, Y0000814 Selamectin, Y0000822 Molsidomine impurity B, Y0001073 Beclometasone dipropionate impurities F and N, Y0001226 Pyridoxine impurity A, Y0001249 Entacapone, Y0001293 Iodixanol impurity H, Y0001356 Nicergoline impurity D, Y0001806 Pregabalin impurity A.

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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