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3 new reference standards and 13 replacement batches released in December 2019

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09 January 2020
Strasbourg, France

See also:
Content of the Ph. Eur. RS catalogue
How to place an RS order


The EDQM announces the availability of:

  • 3 new European Pharmacopoeia (Ph. Eur.) reference standards:

Catalogue code

Name

Unit quantity

Y0002138

Copovidone CRS

65 mg

Y0002141

Fluocortolone pivalate for ID and assay CRS

110 mg

Y0002179

Protamine sulfate CRS

3 mg

 

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

Catalogue code

Name

Batch

Unit quantity

Y0001532

Norethisterone acetate for system suitability CRS

2

2.6 mg

Y0001336

Cefepime impurity E CRS

2

10 mg

Y0000645

Bromazepam for system suitability - * psy CRS

3

15 mg

Y0000152

Sodium Tianeptine for system suitability CRS

2

30 mg

Y0001144

Ganciclovir impurity mixture CRS

2

0.005 mg

Y0000685

Letrozole CRS

2

80 mg

Y0001451

Chlortetracycline for system suitability CRS

3

10 mg

Y0000886

Cyclizine impurity A CRS

2

15 mg

Y0000333

Tiamulin hydrogen fumarate CRS

3

500 mg

Y0000071

Salbutamol impurity D CRS

7

10 mg

Y0000419

Fludarabine phosphate CRS

4

120 mg

Y0002170

Ergometrine impurity mixture - * prec CRS

2

0.002 mg

H1115000

Hyaluronidase BRP

2

50 mg


Information on reference standards removed from catalogue
  • 01/01/2020

Catalogue code

Name

Comments

C2725000

Copovidone - reference spectrum

Replaced by Y0002138 Copovidone CRS

C0580004

Carmustine - reference spectrum

Replaced by Y0002128 Carmustine CRS

N1279000

Norpseudoephedrine hydrochloride CRS - * psy

 

P3640000

Propyl gallate CRS

Replaced by Y0002116 Propyl gallate for ID and assay CRS

Y0000756

Fenoterol for peak identification CRS

 

Y0000779

Chlortalidone for peak identification CRS

Replaced by Y0002129 Chlortalidone for system suitability CRS

Y0001079

Benserazide for peak identification CRS

Replaced by Y0002115 Benserazide for peak identification A CRS

P3600000

Propranolol hydrochloride for performance test CRS

 

Y0001601

Alfacalcidol for system suitability CRS

 


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

 

 

Information on change of sales units

None.


Information on change of EDQM storage/shipping conditions

In order to ensure better stability, storage and shipment conditions will be changed for the following reference standard from 15/01/2020:

  • Enalapril impurity mixture A CRS batch 2 will be stored at –20°C and shipped at +5°C.

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 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 and 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 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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