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15 new reference standards and 16 replacement batches released in September 2019

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03 October 2019
Strasbourg, France

The EDQM announces the availability of:

  • 15 New Ph. Eur. reference standards:

Catalogue code

Name

Unit Quantity

Y0002139

Zolpidem for system suitability CRS

10 mg

Y0002140

Almotriptan for system suitability CRS

10 mg

Y0002144

Almotriptan malate CRS

70 mg

Y0002145

Testosterone impurity I CRS

20 mg

Y0002148

Mercaptopurine impurity B

15 mg

Y0002150

Rosuvastatin for peak identification CRS

15 mg

Y0002152

Mercaptopurine impurity D CRS

15 mg

Y0002153

Tranexamic acid impurity F CRS

10 mg

Y0002154

Tranexamic acid impurity C CRS

10 mg

Y0002155

Tranexamic acid impurity B CRS

15 mg

Y0002156

Exemestane for peak identification CRS

10 mg

Y0002158

Pyrantel impurity C CRS

30 mg

Y0002163

Testosterone for ID and assay CRS

90 mg

Y0002166

Donepezil hydrochloride monohydrate CRS

20 mg

Y0002168

Sulfamethizole for system suitability CRS

10 mg

 

  • 16 Replacement batches for Ph. Eur. reference standards:

Catalogue code

Name

Batch

Unit
Quantity

B0700000

Benzylpenicillin potassium CRS

3

100 mg

C0460000

Carbidopa CRS

3

50 mg

D0600000

Deslanoside CRS

3

160 mg

P2669000

Prazepam CRS

2

15 mg

Y0000005

Amphotericin B CRS

6

100 mg

Y0000097

Mesterolone CRS

3

120 mg

Y0000768

Etodolac for peak identification CRS

3

0.41 mg

Y0001032

Lamotrigine impurity E CRS

2

15 mg

Y0001037

Meloxicam impurity C CRS

4

10 mg

Y0001117

Amikacin for system suitability CRS

4

15 mg

Y0001128

Epinastine for system suitability CRS

2

10 mg

Y0001146

Cimetidine for system suitability CRS

2

0.51 mg

Y0001179

Tiotropium impurity mixture CRS

3

0.08 mg

Y0001433

Montelukast racemate CRS

4

0.1 mg

Y0001695

Imatinib impurity A CRS

2

0.03 mg

Y0001734

Selamectin for peak identification CRS

3

5 mg

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, due to the delays to get the export permits (10 weeks), we are no longer able to send this item before 01/01/20. Orders from outside France are, therefore, unfortunately, no longer accepted. The deliveries to 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:

From 01/07/2019, the number of vials per sales unit is increased from 2 to 3 for:
A0325450      Alfacalcidol

 

 

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 stored at -20°C and shipped at -20 °C (batch 3 was stored at +5 °C and shipped ambient).

 

In order to ensure better stability, storage and shipping conditions will be changed for the following reference standard on 16/10/2019:

Catalogue code

Name

Storage conditions

Shipping conditions

Y0002055

Fingolimod hydrochloride CRS

Current: -20°C

Future: +5°C

Current: Ice -20°C

Future: Ambient

 

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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