Council for europe portal
Language : en Search
Choose language

7 new reference standards and 23 replacement batches released in October 2019

Back
Products and Services
News
04 November 2019
Strasbourg, France

The EDQM announces:

Content of the Ph. Eur. RS catalogue

How to place an RS order

 

 

Catalogue code

Name

Unit quantity

Y0002147

Mercaptopurine impurity A CRS

15 mg

Y0002131

Squalene

500 mg

Y0002167

Rosuvastatin impurity mixture CRS

0.002 mg

Y0002157

Fluocortolone pivalate for system suitability CRS

10 mg

Y0002106

Octreotide impurity mixture CRS

0.01 mg

Y0002105

Octreotide for NMR identification CRS

2 mg

Y0002104

Octreotide CRS

11 mg

 

 

 

 

 

Catalogue code

Name

Batch

Unit quantity

Y0001111

Ceftazidime for peak identification CRS

3

13 mg

Y0001048

Levodropropizine impurity C CRS

2

420 mg

X0080000

Xylitol CRS

3

220 mg

Y0000583

Valerian dry extract HRS

4

500 mg

R0900000

Rifamycin B CRS

4

25 mg

I0320301

Interferon alfa-2b CRS

7

200 µL

Q0200000

Quinine sulfate CRS

3

300 mg

Y0000081

Articaine impurity E CRS

3

10 mg

Y0001194

Resveratrol CRS

2

25 mg

L0720000

Lithium clavulanate CRS

9

125 mg

Y0001219

Captopril impurity B CRS

2

10 mg

Y0000747

Moxidectin for system suitability CRS

3

10 mg

C3000000

Cyanocobalamin CRS

6

20 mg

Y0001682

Gemcitabine impurity C CRS

2

5 mg

Y0001477

Dexamethasone sodium phosphate for peak identification CRS

2

10 mg

N0401000

Neomycin sulfate for microbiological assay CRS

6

25 mg

D1050000

Dicloxacillin sodium CRS

6

250 mg

Y0001741

Permethrin for system suitability CRS

3

60 mg

Y0001447

Celecoxib impurity B CRS

3

10 mg

Y0001138

Phenazone impurity A CRS

2

20 mg

Y0001647

Vardenafil hydrochloride CRS

2

130 mg

Y0001484

Medroxyprogesterone acetate for peak identification CRS

2

25 mg

C2150000

Cholecalciferol for system suitability CRS

9

1 mL

 

 

 

Information on reference standards removed from catalogue:

None.

 

 

Information on reference standards with a future removal from catalogue:

  • 01/01/2020

Catalogue code

Name

Comments

C2725000

Copovidone – reference spectrum

 

C0580004

Carmustine – reference spectrum

Replaced by Y0002128 Carmustine CRS

N1279000

Norpseudoephedrine hydrochloride CRS – * psy

Unfortunately, delays in obtaining export permits (10 weeks), prevent us from sending this item before 01/01/20. For this reason, orders from outside France are no longer accepted. Deliveries in France are still possible.

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

Y0001601

Alfacalcidol for system suitability CRS

 

 

  • 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 shipping conditions have been changed for the following reference standard.

  • Thiopental for system suitability CRS batch 4 is now stored at –20°C and shipped at
    –20°C (batch 3 was stored at +5°C and shipped at ambient temperature).
  • Fingolimod hydrochloride CRS batch 1 is now stored at +5°C and shipped at ambient temperature (the same batch was previously stored at –20°C and shipped at –20°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 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 e-mail to orders@edqm.eu (in this case, please ensure that your order is on your company letterhead paper, that it states both the catalogue code and substance name and is attached to your e-mail).
twitter facebook googleplus pinterest linkedin email