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6 new reference standards and 16 replacement batches released in July 2021

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05 August 2021
Strasbourg, France

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The EDQM announces the availability of:

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

Catalogue code

Name

Unit quantity

Price

Y0002315

Atorvastatin calcium CRS

150 mg

79 EUR

Y0002288

Chelerythrine chloride CRS

25 mg

79 EUR

Y0002284

Phenoxybenzamine for system suitability SCR

10 mg

79 EUR

Y0002282

Phenoxybenzamine hydrochloride CRS

80 mg

79 EUR

Y0002283

Phenoxybenzamine impurity B SCR

10 mg

79 EUR

Y0002307

Palladium solution

10.2 mL

79 EUR

 

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0001755

Fluticasone propionate for impurity G identification CRS

2

15 mg

79 EUR

L0399905

Levocarnitine impurity A CRS

5

30 mg

79 EUR

Y0000395

Granisetron impurity E CRS

4

15 mg

79 EUR

S0780000

Sodium hyaluronate BRP

3

300 mg

79 EUR

S0765000

Diclofenac sodium CRS

5

80 mg

79 EUR

Y0001722

Rosuvastatin impurity G CRS

4

0.004 mg

79 EUR

Y0000135

Diphenhydramine impurity A CRS

5

20 mg

79 EUR

Y0001381

Glucosamine for system suitability CRS

3

3 mg

79 EUR

N1200000

Norethisterone CRS

4

25 mg

79 EUR

Y0000225

Oxfendazole with impurity D CRS

2

20 mg

79 EUR

C1900000

Chlorpromazine hydrochloride CRS

2

150 mg

79 EUR

Y0000587

Venlafaxine hydrochloride CRS

3

50 mg

79 EUR

Y0002242

Aciclovir for impurity C identification CRS

2

0.3 mg

79 EUR

P0600002

Pethidine impurity A CRS

3

20 mg

79 EUR

D0430000

Dequalinium chloride

2

50 mg

79 EUR

Y0000684

Trimethoprim for system suitability CRS

5

0.00075 mg

79 EUR

 

Information on reference standards removed from catalogue

  • Supplement 10.4

Following the implementation of Supplement 10.4, the following standards are officially withdrawn from 1 April 2021.

Catalogue code

Name

Comments

Y0001846

Erythromycin for impurity M identification

These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of September 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 31 March 2022) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

A0650000

Amobarbital - * psy

A0700000

Amobarbital sodium - * psy

D0630000

Desmethylmetrifonate

M1845000

Metrifonate

Y0001328

Atorvastatin impurity A

Y0001329

Atorvastatin impurity B

Y0001330

Atorvastatin impurity C

Y0001331

Atorvastatin impurity D

Y0001264

Aciclovir for system suitability

Y0001755

Fluticasone propionate for impurity G identification

Y0001271

Aciclovir for peak identification 1

Y0002077

Procaine benzylpenicillin for peak identification

Y0001269

Aciclovir for peak identification 2

  • Supplement 10.5

Following the implementation of Supplement 10.5, the following standards are officially withdrawn from 1 July 2021.

D1750000

Diflunisal

These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of December 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 July 2022) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0000334

Codeine impurity A (O-methylcodeine)

Y0001641

Zidovudine for system suitability

Y0000361

Ciclosporin for system suitability

T0700000

Theobromine

 

Information on reference standards with a future removal from catalogue

  • Supplement 10.6

Following the implementation of Supplement 10.6 (1 January 2022), the following standards will be removed from the catalogue.

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

 

The following standards will also be removed and replaced.

Items removed

Catalogue code

Replaced by

Catalogue code

Bisacodyl for system suitability

Y0000694

Bisacodyl for system suitability A

Y0002272

Dipotassium clorazepate - reference spectrum

D2750100

Dipotassium clorazepate monohydrate CRS

Y0002276

Terazosin for system suitability

Y0000666

Terazosin for system suitability A CRS

Y0002286

Terazosin impurity A

Y0000622

Terazosin for system suitability A CRS

Y0002286

Nitrofural for peak identification

Y0001377

Nitrofural for peak indentification A CRS

Y0002295

Pravastatin 1,1,3,3-tetramethylbutylamine

Y0000204

Pravastatin 1,1,3,3-tetramethylbutylamine for assay CRS

Y0002294

 

Information on change of sales units

Cholesterol CRS, C2155000 – sales unit is changed (6 July 2021) from one to two units.

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

Due to stability issue, shipping conditions have been modified on 1 July 2021 for the following reference standard:

  • Prilocaine (P2939000) CRS batch 2 is shipped under Ice +5°C (previously ambient).

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 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 web store;
  • 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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