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3 new reference standards and 11 replacement batches released in December 2021

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Reference Standard
Collection & Catalogue
News
07 January 2022
Strasbourg, France

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The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the availability of:

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

Catalogue code

Name

Unit quantity

Price

Y0002312

Dydrogesterone for impurity A identification

0.002 mg

79 EUR

Y0002324

Flucloxacillin for peak identification CRS

15 mg

79 EUR

Y0002313

Domperidone impurity mixture

0.04 mg

79 EUR

 

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0000811

Acemetacin impurity A CRS

2

20 mg

79 EUR

Y0001003

Telmisartan for system suitability CRS

6

0.26 mg

79 EUR

Y0001478

Thiopental for system suitability CRS

5

10 mg

79 EUR

O0700000

Oxytocin CRS

7

41 mg

90 EUR

Y0001390

Cyproterone acetate for peak identification CRS

2

15 mg

79 EUR

Y0001549

Oxcarbazepine impurity mixture CRS

2

0.008 mg

79 EUR

Y0000723

Thebaine CRS - * narc

2

15 mg

79 EUR

Y0002310

Atorvastatin impurity mixture CRS

2

0.03 mg

79 EUR

Y0000405

Salicylic acid impurity B CRS

4

15 mg

79 EUR

Y0001714

Doxycycline for system suitability CRS

4

10 mg

79 EUR

Y0001832

Irinotecan hydrochloride trihydrate CRS

2

170 mg

79 EUR

 

Information on reference standards removed from catalogue

  • Supplement 10.6 

Following the implementation of Supplement 10.6, the following standards are officially withdrawn from 1 January 2022.

B0300000

Barbital

These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of June 2022. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 January 2023) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0000623

Terazosin impurity L

Y0000694

Bisacodyl for system suitability

D2750100

Dipotassium clorazepate - reference spectrum

Y0000666

Terazosin for system suitability

Y0000622

Terazosin impurity A

Y0001377

Nitrofural for peak identification

Y0000204

Pravastatin 1,1,3,3-tetramethylbutylamine

 

Information on reference standards with a future removal from catalogue

  • Supplement 10.7

Following the implementation of Supplement 10.7, the following standards will be officially withdrawn from 1 April 2022.

Y0001327

Atorvastatin calcium trihydrate

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 October 2022. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 April 2023) to allow users to print the BVS. See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0001332

Atorvastatin impurity E

Y0000340

Formoterol fumarate for system suitability

Y0000820

Marbofloxacin for peak identification

Y0002229

Atorvastatin for system suitability

Y0001478

Thiopental for system suitability

Y0002137

Alfacalcidol for impurity B identification

S0400000

Senna extract CRS

D2630000

Diphenoxylate hydrochloride - reference spectrum

Y0001942

Gonadorelin for system suitability

 

  • Supplement 10.8

Following the implementation of Supplement 10.8, the following standards will be officially withdrawn from 1 July 2022.

Y0000645

Bromazepam for system suitability

These standards will nevertheless remain available for sale, subject to sufficient stock, until 1 January 2023. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 July 2023) to allow users to print the BVS. See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0001005

Dydrogesterone impurity A

 

Information on change of sales units

None.

 

Information on change of price

Please note the price change for Batch 2 of Everolimus CRS and Everolimus for impurity C identification CRS, to €300 per sales unit.

 

Information on change of EDQM storage/shipping conditions

Based on new stability information, shipping conditions were changed on 17 December 2021 for the following reference standard:

  • Regorafenib FP-B (Y0002227) CRS batch 1 is shipped on Ice +5°C (previously ambient temperature).

 

Content of the European Pharmacopoeia RS catalogue

The EDQM proposes 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 PDFs).

For your convenience, the Ph. Eur. RS catalogue is published daily and can be downloaded in PDF format and in XML format.

When stocks of a given reference standard are low, the EDQM reserves the right to limit the quantities sold to each user to ensure that as many users as possible will receive at least some of the quantities available. Restrictions on quantities are applied at the time the purchase order is received.

Following a request from many users, the quantities allowed in case of sales restrictions now appear in the online catalogue as well as in the catalogue in XML format.

 

How to place an RS order

If you wish to place an order, you can send your request to the EDQM either:

  • via the WebStore;
  • 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).

A video has been prepared to help user ordering through the RS WebStore.

 

 

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