Council for europe portal
Language : en Search
Choose language

9 new reference standards and 18 replacement batches released in April 2020

Back
Reference Standard
Collection & Catalogue
News
06 May 2020
Strasbourg, France

 

See also:

Content of the Ph. Eur. RS catalogue

How to place an RS order

 

The EDQM announces the availability of:

  • 9 New Ph. Eur. reference standards:

Catalogue code

Name

Unit Quantity

Y0002217

Betiatide impurity D

10 mg

Y0002216

Betiatide

20 mg

Y0002196

Deferasirox CRS

70 mg

Y0002214

Celiprolol for system suitability CRS

20 mg

Y0002201

Fluoxetine impurity A CRS

15 mg

Y0002202

Ofloxacin impurity D CRS

20 mg

Y0002198

Deferasirox impurity B CRS

10 mg

Y0002193

Rivaroxaban for system suitability CRS

5 mg

Y0002188

Rivaroxaban impurity A CRS

5 mg

 

 

  • 18 Replacement batches of Ph. Eur. reference standards:

Catalogue code

Name

Batch

Unit
Quantity

Y0000280

Chondroitin sulfate sodium CRS

3

350 mg

Y0000753

Fexofenadine impurity C CRS

2

5 mg

Y0000631

Naproxen impurity L CRS

3

15 mg

T2500100

Trimyristin CRS

3

1000 mg

H1429400

Hydroxyethyl salicylate CRS

3

125 mg

Y0001388

Candesartan cilexetil CRS

2

60 mg

Y0000797

Promethazine for peak identification CRS

3

5 mg

Y0000739

Paclitaxel semi-synthetic for system suitability CRS

3

1.01 mg

A0070020

Acesulfame potassium impurity B CRS

5

15 mg

Y0001535

Pemetrexed impurity mixture CRS

3

0.002 mg

Y0001533

Praziquantel for system suitability CRS

2

10 mg

Y0001474

Lauric acid CRS

2

1500 mg

N0845008

Nimesulide impurity D CRS

6

0.004 mg

D0201000

Dehydrohexetidine CRS

3

50 mg

Y0000737

Flavoxate impurity A CRS

2

15 mg

O0250000

Oxprenolol hydrochloride CRS

2

50 mg

F0285202

Flurbiprofen impurity A CRS

4

25 mg

D0718000

Dexamethasone pivalate CRS

2

50 mg

 

Information on price change

Please note that the price of Everolimus CRS, Everolimus for system suitability CRS and Everolimus for impurity C identification CRS batch 2 will be changed to €300.

 

Information on reference standards removed from the catalogue:

As of 1 April 2020, the following standards have been removed from the catalogue.

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 reference standards to be removed from the catalogue in future:

  • 2 July 2021

Catalogue code

Name

Comments

C2332000

Clomifene citrate for performance test CRS

Removed from Ph. Eur. Supplement 10.2 (in effect from 1 July 2020) but kept on sale for an additional 6 months according to policy

Y0001850

Oxytetracycline for system suitability CRS

 

Information on change of sales units:

None.

 

 

Information on changes to EDQM storage/shipping conditions:

In order to ensure better stability, storage and shipping conditions will be changed on 15 May 2020 for the following reference standards:

  • Calcifediol for impurity D identification CRS batch 1 will be stored at +5 °C (previously -20 °C) and shipped at ambient temperature (previously Ice -20 °C).
  • Calcifediol CRS batch 6 will be stored at +5 °C (previously -20 °C) and shipped at ambient temperature (previously Ice -20 °C)

 

Change in the policy for withdrawing reference standards from sale

At the present time, a reference standard is withdrawn from the catalogue either on the date that a revised monograph which no longer refers to it becomes applicable, or the date on which a monograph is officially withdrawn from the Ph. Eur.

A number of users have informed us that regulatory requirements in their country permit the use of these reference standards (and therefore the corresponding monographs) even after their official withdrawal date. To help these users, the EDQM has decided to modify its withdrawal policy.

Therefore, stocks permitting, sale of these reference standards will continue for 6 months after the official withdrawal date. Similarly, they will remain in the catalogue for a period of 12 months to allow users to print the Batch Validity Statement (BVS) and/or finalise the necessary procedures for controlled substances.

Example:

Fluocortolone pivalate CRS (F0230000) was used in monograph 1212.

The revised monograph entered into force on 1 April 2020.

 

Current situation:

Reference standard F0230000 would have been withdrawn from sale on 1 April 2020.

New policy:

Reference standard F0230000 will be available for purchase until 1 October 2020 (1 April 2020 + 6 months) and will feature in the catalogue until 1 April 2021 (1 April 2020 + 1 year).

 

Note: although it will still be listed in the catalogue until 1 April 2021, it will not be possible to order the reference standard after 1 October 2020.

 

The validity of this standard will thus end on 2 April 2021. As of this date, it will no longer be displayed in the catalogue and therefore can no longer be used.

 

This policy will be applied from the application of Supplement 10.2 (1 July 2020).

 

 

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 monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin) and 0952 (Somatropin for injection) by using 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 offers more than 3 000 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 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 is attached to your email).
twitter facebook googleplus pinterest linkedin email