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9 new reference standards and 20 replacement batches released in November 2019

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03 December 2019
Strasbourg, France

Content of the Ph. Eur. RS catalogue

How to place an RS order


The EDQM announces the availability of:

 

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

Catalogue code

Name

Unit quantity

Y0002165

Donepezil for system suitability CRS

10 mg

Y0002160

Donepezil hydrochloride CRS

50 mg

Y0002164

Clobetasol propionate for peak identification CRS

2 mg

Y0002162

Tranexamic acid impurity D CRS

15 mg

Y0002149

Tranexamic acid impurity E CRS

10 mg

Y0002161

Nomegestrol acetate for ID and assay CRS

70 mg

Y0002126

Vincamine for system suitability CRS

10 mg

Y0002169

Nomegestrol acetate impurity B CRS

0.0008 mg

Y0002130

Hibifolin CRS

15 mg

 

 

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

Catalogue code

Name

Batch

Unit quantity

Y0000451

Morphine hydrochloride trihydrate CRS

4

30 mg

G0525000

Gonadorelin CRS

7

5 mg

Y0002011

Zoledronic acid impurity A CRS

2

15 mg

Y0000410

Naltrexone impurity C CRS

2

15 mg

Y0000222

Moxonidine impurity A CRS

2

15 mg

C0694990

Cefuroxime axetil CRS

5

70 mg

Y0000637

Azithromycin for peak identification CRS

5

20 mg

F0400000

Fosfomycin trometamol CRS

5

1500

Y0000883

Adrenaline with impurity F CRS

2

0.008 mg

Y0000018

Propofol impurity J CRS

5

20 mg

C2219000

Citric acid monohydrate CRS

2

50 mg

C0684750

Cefoperazone dihydrate CRS

3

110 mg

Y0000758

Clozapine for peak identification CRS

3

0.41 mg

Y0001993

Sevoflurane for system suitability CRS

2

0.5 mL

Y0000462

Torasemide for system suitability CRS

3

5 mg

Y0001578

Sildenafil citrate CRS

2

100 mg

A1100000

Ampicillin trihydrate CRS

3

150 mg

Y0001478

Thiopental for system suitability CRS

4

10 mg

Y0001339

Oseltamivir impurity B CRS

2

10 mg

B1212000

Butylhydroxyanisole CRS

5

60 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 in obtaining export permits (10 weeks), we are no longer able to send this item before 01/01/20. Orders from outside France can therefore 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 will be changed for the following reference standard from 16/12/2019:

  • Simvastatin imp. K CRS batch 2 will be stored at +5°C and shipped at ambient temperature.

  • Griseofulvin for LC assay and id CRS batch 1 will be 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. 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 stating both the catalogue code and substance name and attached to your e-mail).
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