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29 new Ph. Eur. Reference Substances (RS) and 18 replacement batches released in January 2019

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07 February 2019
Strasbourg, France

The EDQM announces the availability of:

29 New Ph. Eur. Reference Substances:

Y0002048 Everolimus, Y0002053 Achyranthes bidentata root dry extract for system suitability, Y0002054 Beta-Ecdysterone, Y0002057 Corydalis rhizome dry extract, Y0002076 Asparagine impurity C, Y0002078 moxifloxacin for system suitability, Y0002079 Mebeverine hydrochloride, Y0002080 Vancomycin for system suitability, Y0002081 Moxifloxacin for peak identification B, Y0002082 Prochlorperazine for system suitability, Y0002083 Methyl salicylate, Y0002084 Levofloxacin impurity F, Y0002085 Levofloxacin hemihydrate, Y0002088 Chlorprothixene for system suitability, Y0002089 Levofloxacin for system suitability, Y0002091 Regorafenib impurity C, Y0002092 Regorafenib impurity D, Y0002093 Regorafenib impurity A, Y0002094 Flupentixol for system suitability, Y0002095 Prazosin impurity A, Y0002098 Sorafenib, Y0002099 Moxifloxacin for peak identification A, Y0002100 Nilotinib for system suitability, Y0002101 Pantothenate for peak identification, Y0002103 Nilotinib impurity A, Y0002107 Mebeverine for system suitability, Y0002108 Nilotinib impurity C, Y0002109 Pantolactone, Y0002111 Nilotinib impurity B

18 Replacement batches for Ph. Eur. Reference Substances:

D0736000 Dextran 70 for calibration, D2205000 Dimetindene maleate, I0320000 Insulin (porcine), P0090000 Palmitic acid, R0145020 Ramipril impurity D, Y0000088 Bupivacaine impurity B, Y0000130 Amiodarone impurity E, Y0000177 Erythritol, Y0000416 Ranitidine impurity J, Y0000435 Captopril impurity E, Y0000581 Paroxetine hydrochloride (anhydrous) impurity H, Y0001120 Adapalene impurity C, Y0001167 Phenytoin for system suitability, Y0001172 Trehalose dehydrate, Y0001389 Candesartan cilexetil for system suitability, Y0001398 Voriconazole impurity D, Y0001498 Lopinavir, Y0001709 Lisinopril for system suitability A

6 Withdrawn products for Ph. Eur. Reference Substances:

Y0000247 Ebastine impurity C, Y0000248 Ebastine impurity D, Y0000249 Ebastine - reference spectrum, Y0000277 Colistin sulfate, Y0000302 Ammonio methacrylate copolymer(type A) - reference spectrum, Y0000303 Ammonio methacrylate copolymer(type B) - reference spectrum

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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